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LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-N

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20

Approved
Approval ID

f459c27e-e607-47ba-e053-2a95a90a901f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 22, 2025

Manufacturers
FDA

BEL STAR SA

DUNS: 880160197

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14141-324
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
OCTINOXATE, ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 22, 2025
FDA Product Classification

INGREDIENTS (36)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive
Code: H895X08VNQ
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BACKHOUSIA CITRIODORA LEAFInactive
Code: FKN73KG747
Classification: IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: 00BT03FSO2
Classification: IACT
PERFLUOROOCTYL TRIETHOXYSILANEInactive
Code: 814P46684U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HYDROXYETHYL UREAInactive
Code: MBQ7DDQ7AR
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OCTYLDODECETH-25Inactive
Code: F8934HEL3M
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DECYLENE GLYCOLInactive
Code: S57M60MI88
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OCTINOXATEActive
Quantity: 50 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
ZINC OXIDEActive
Quantity: 42 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PEG-10 DIMETHICONE (220 CST)Inactive
Code: 287GF3Y3WC
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14141-323
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
OCTINOXATE, ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 22, 2025
FDA Product Classification

INGREDIENTS (36)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive
Code: H895X08VNQ
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BACKHOUSIA CITRIODORA LEAFInactive
Code: FKN73KG747
Classification: IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: 00BT03FSO2
Classification: IACT
PERFLUOROOCTYL TRIETHOXYSILANEInactive
Code: 814P46684U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HYDROXYETHYL UREAInactive
Code: MBQ7DDQ7AR
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OCTYLDODECETH-25Inactive
Code: F8934HEL3M
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DECYLENE GLYCOLInactive
Code: S57M60MI88
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OCTINOXATEActive
Quantity: 50 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
ZINC OXIDEActive
Quantity: 42 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PEG-10 DIMETHICONE (220 CST)Inactive
Code: 287GF3Y3WC
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14141-322
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
OCTINOXATE, ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 22, 2025
FDA Product Classification

INGREDIENTS (36)

CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive
Code: H895X08VNQ
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BACKHOUSIA CITRIODORA LEAFInactive
Code: FKN73KG747
Classification: IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: 00BT03FSO2
Classification: IACT
PERFLUOROOCTYL TRIETHOXYSILANEInactive
Code: 814P46684U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HYDROXYETHYL UREAInactive
Code: MBQ7DDQ7AR
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OCTYLDODECETH-25Inactive
Code: F8934HEL3M
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DECYLENE GLYCOLInactive
Code: S57M60MI88
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OCTINOXATEActive
Quantity: 50 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
ZINC OXIDEActive
Quantity: 42 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PEG-10 DIMETHICONE (220 CST)Inactive
Code: 287GF3Y3WC
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14141-321
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
OCTINOXATE, ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 22, 2025
FDA Product Classification

INGREDIENTS (36)

DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive
Code: H895X08VNQ
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BACKHOUSIA CITRIODORA LEAFInactive
Code: FKN73KG747
Classification: IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: 00BT03FSO2
Classification: IACT
PERFLUOROOCTYL TRIETHOXYSILANEInactive
Code: 814P46684U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HYDROXYETHYL UREAInactive
Code: MBQ7DDQ7AR
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OCTYLDODECETH-25Inactive
Code: F8934HEL3M
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DECYLENE GLYCOLInactive
Code: S57M60MI88
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OCTINOXATEActive
Quantity: 50 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
ZINC OXIDEActive
Quantity: 42 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
PEG-10 DIMETHICONE (220 CST)Inactive
Code: 287GF3Y3WC
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14141-325
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
OCTINOXATE, ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 22, 2025
FDA Product Classification

INGREDIENTS (36)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)Inactive
Code: H895X08VNQ
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BACKHOUSIA CITRIODORA LEAFInactive
Code: FKN73KG747
Classification: IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: 00BT03FSO2
Classification: IACT
PERFLUOROOCTYL TRIETHOXYSILANEInactive
Code: 814P46684U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HYDROXYETHYL UREAInactive
Code: MBQ7DDQ7AR
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OCTYLDODECETH-25Inactive
Code: F8934HEL3M
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DECYLENE GLYCOLInactive
Code: S57M60MI88
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OCTINOXATEActive
Quantity: 50 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
ZINC OXIDEActive
Quantity: 42 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PEG-10 DIMETHICONE (220 CST)Inactive
Code: 287GF3Y3WC
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/10/2023

Package Label ALMENDRA 230-N

5

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/10/2023

Uses

  • Helps prevent sunburn.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/10/2023

Other information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/10/2023

Company Information

U.S.A. & PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926, Made in Colombia.

www.lbel.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/10/2023

Active ingredients

Octinoxate 5.00%

Zinc oxide 4.20%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/10/2023

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 2/10/2023

Warnings

***Skin Cancer/Skin Aging Alert:**Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. *For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/10/2023

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/10/2023

Inactive ingredients

Water, Dimethicone, Isododecane, Peg-10 Dimethicone, Trimethylsiloxysilicate, Propylene Glycol, Mica, Dimethicone/vinyl Dimethicone Crosspolymer, Peg/ppg-18/18 Dimethicone, Polysilicone-11, Glycerin, Lecithin, Sodium Chloride, Phenoxyethanol, Silica, Silica Dimethyl Silylate, Backhousia Citriodora Leaf Extract, Maltodextrin, Caprylyl Glycol, Disteardimonium Hectorite, Hydroxyethyl Urea, Peg-8 Caprylic/capric Glycerides, Chlorphenesin, Tocopheryl Acetate, Lactobacillus Ferment, Octyldodeceth-25, Perfluorohexylethyl Triethoxysilane, Sodium Hyaluronate, Decylene Glycol.

May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane.

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