LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 BEIGE 220C

LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15

Approved

Approval ID

35c106b6-9a80-01e3-e063-6294a90abc35

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers

FDA

BEL STAR S.A.

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 Code14141-387

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE, ZINC OXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 22, 2025

FDA Product Classification

INGREDIENTS (31)

POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive

Code: 59Z907ZB69

Classification: IACT

PEG/PPG-18/18 DIMETHICONEInactive

Code: 9H0AO7T794

Classification: IACT

AMYL SALICYLATEInactive

Code: VZO9C30208

Classification: IACT

TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENESInactive

Code: 2JU6ZH6GRE

Classification: IACT

ALPHA-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

OCTINOXATEActive

Quantity: 50 mg in 1 g

Code: 4Y5P7MUD51

Classification: ACTIB

PEG-10 DIMETHICONE (220 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

CHLORPHENESINInactive

Code: I670DAL4SZ

Classification: IACT

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERInactive

Code: WB5K9Y35Y9

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

SACCHARIDE ISOMERATEInactive

Code: W8K377W98I

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHEA BUTTERInactive

Code: K49155WL9Y

Classification: IACT

ZEA MAYS (CORN) STARCHInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEInactive

Code: X2PZH4Y6HT

Classification: IACT

ALOE VERA LEAF JUICEInactive

Code: RUE8E6T4NB

Classification: IACT

CI 77491Inactive

Code: 1K09F3G675

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ZINC OXIDEActive

Quantity: 29.4 mg in 1 g

Code: SOI2LOH54Z

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PENTYLENE GLYCOLInactive

Code: 50C1307PZG

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive

Code: 9E4CO0W6C5

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

CI 77499Inactive

Code: XM0M87F357

Classification: IACT

CI 77492Inactive

Code: EX438O2MRT

Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code14141-390

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE, ZINC OXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 22, 2025

FDA Product Classification

INGREDIENTS (31)

POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive

Code: 59Z907ZB69

Classification: IACT

PEG/PPG-18/18 DIMETHICONEInactive

Code: 9H0AO7T794

Classification: IACT

AMYL SALICYLATEInactive

Code: VZO9C30208

Classification: IACT

TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENESInactive

Code: 2JU6ZH6GRE

Classification: IACT

ALPHA-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

OCTINOXATEActive

Quantity: 50 mg in 1 g

Code: 4Y5P7MUD51

Classification: ACTIB

PEG-10 DIMETHICONE (220 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERInactive

Code: WB5K9Y35Y9

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

SACCHARIDE ISOMERATEInactive

Code: W8K377W98I

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHEA BUTTERInactive

Code: K49155WL9Y

Classification: IACT

ZEA MAYS (CORN) STARCHInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEInactive

Code: X2PZH4Y6HT

Classification: IACT

ALOE VERA LEAF JUICEInactive

Code: RUE8E6T4NB

Classification: IACT

CI 77499Inactive

Code: XM0M87F357

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ZINC OXIDEActive

Quantity: 29.4 mg in 1 g

Code: SOI2LOH54Z

Classification: ACTIB

CHLORPHENESINInactive

Code: I670DAL4SZ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PENTYLENE GLYCOLInactive

Code: 50C1307PZG

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive

Code: 9E4CO0W6C5

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

CI 77491Inactive

Code: 1K09F3G675

Classification: IACT

CI 77492Inactive

Code: EX438O2MRT

Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code14141-391

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE, ZINC OXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 22, 2025

FDA Product Classification

INGREDIENTS (31)

POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive

Code: 59Z907ZB69

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERInactive

Code: WB5K9Y35Y9

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

SACCHARIDE ISOMERATEInactive

Code: W8K377W98I

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHEA BUTTERInactive

Code: K49155WL9Y

Classification: IACT

ZEA MAYS (CORN) STARCHInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

PEG/PPG-18/18 DIMETHICONEInactive

Code: 9H0AO7T794

Classification: IACT

AMYL SALICYLATEInactive

Code: VZO9C30208

Classification: IACT

TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENESInactive

Code: 2JU6ZH6GRE

Classification: IACT

OCTINOXATEActive

Quantity: 50 mg in 1 g

Code: 4Y5P7MUD51

Classification: ACTIB

PEG-10 DIMETHICONE (220 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

ALPHA-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEInactive

Code: X2PZH4Y6HT

Classification: IACT

ALOE VERA LEAF JUICEInactive

Code: RUE8E6T4NB

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ZINC OXIDEActive

Quantity: 29.4 mg in 1 g

Code: SOI2LOH54Z

Classification: ACTIB

CHLORPHENESINInactive

Code: I670DAL4SZ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PENTYLENE GLYCOLInactive

Code: 50C1307PZG

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive

Code: 9E4CO0W6C5

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

CI 77491Inactive

Code: 1K09F3G675

Classification: IACT

CI 77492Inactive

Code: EX438O2MRT

Classification: IACT

CI 77499Inactive

Code: XM0M87F357

Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code14141-388

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE, ZINC OXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 22, 2025

FDA Product Classification

INGREDIENTS (31)

CI 77492Inactive

Code: EX438O2MRT

Classification: IACT

CI 77499Inactive

Code: XM0M87F357

Classification: IACT

POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive

Code: 59Z907ZB69

Classification: IACT

PEG/PPG-18/18 DIMETHICONEInactive

Code: 9H0AO7T794

Classification: IACT

AMYL SALICYLATEInactive

Code: VZO9C30208

Classification: IACT

TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENESInactive

Code: 2JU6ZH6GRE

Classification: IACT

ALPHA-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

OCTINOXATEActive

Quantity: 50 mg in 1 g

Code: 4Y5P7MUD51

Classification: ACTIB

PEG-10 DIMETHICONE (220 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERInactive

Code: WB5K9Y35Y9

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

SACCHARIDE ISOMERATEInactive

Code: W8K377W98I

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHEA BUTTERInactive

Code: K49155WL9Y

Classification: IACT

ZEA MAYS (CORN) STARCHInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEInactive

Code: X2PZH4Y6HT

Classification: IACT

ALOE VERA LEAF JUICEInactive

Code: RUE8E6T4NB

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ZINC OXIDEActive

Quantity: 29.4 mg in 1 g

Code: SOI2LOH54Z

Classification: ACTIB

CHLORPHENESINInactive

Code: I670DAL4SZ

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive

Code: 9E4CO0W6C5

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PENTYLENE GLYCOLInactive

Code: 50C1307PZG

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

CI 77491Inactive

Code: 1K09F3G675

Classification: IACT

OCTINOXATE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code14141-389

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

OCTINOXATE, ZINC OXIDE

Product Specifications

Route of AdministrationTOPICAL

Effective DateMay 22, 2025

FDA Product Classification

INGREDIENTS (31)

POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive

Code: 59Z907ZB69

Classification: IACT

PEG/PPG-18/18 DIMETHICONEInactive

Code: 9H0AO7T794

Classification: IACT

AMYL SALICYLATEInactive

Code: VZO9C30208

Classification: IACT

TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENESInactive

Code: 2JU6ZH6GRE

Classification: IACT

ALPHA-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08E

Classification: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438U

Classification: IACT

OCTINOXATEActive

Quantity: 50 mg in 1 g

Code: 4Y5P7MUD51

Classification: ACTIB

PEG-10 DIMETHICONE (220 CST)Inactive

Code: 287GF3Y3WC

Classification: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3T

Classification: IACT

DISTEARDIMONIUM HECTORITEInactive

Code: X687XDK09L

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERInactive

Code: WB5K9Y35Y9

Classification: IACT

ISODODECANEInactive

Code: A8289P68Y2

Classification: IACT

SACCHARIDE ISOMERATEInactive

Code: W8K377W98I

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHEA BUTTERInactive

Code: K49155WL9Y

Classification: IACT

ZEA MAYS (CORN) STARCHInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEInactive

Code: X2PZH4Y6HT

Classification: IACT

ALOE VERA LEAF JUICEInactive

Code: RUE8E6T4NB

Classification: IACT

CI 77492Inactive

Code: EX438O2MRT

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

ZINC OXIDEActive

Quantity: 29.4 mg in 1 g

Code: SOI2LOH54Z

Classification: ACTIB

CHLORPHENESINInactive

Code: I670DAL4SZ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PENTYLENE GLYCOLInactive

Code: 50C1307PZG

Classification: IACT

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive

Code: 9E4CO0W6C5

Classification: IACT

TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive

Code: 5041RX63GN

Classification: IACT

CI 77499Inactive

Code: XM0M87F357

Classification: IACT

CI 77491Inactive

Code: 1K09F3G675

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/3/2025

Product Label CAPUCCINO 310C

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/3/2025

Uses

Helps prevent sunburn

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/3/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/3/2025

Active Ingredients

OCTINOXATE 5.00 %

ZINC OXIDE 2.94 %

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/3/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 3/3/2025

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,notskin 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: 3/3/2025

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.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 3/3/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/3/2025

Inactive ingredients

Water, dimethicone, isododecane, trimethylsiloxysilicate, glycerin, saccharide isomerate, peg/ppg-18/18 dimethicone, butyrospermum parkii (shea) butter, peg-10 dimethicone, polysilicone-11, zea mays (corn) starch, polymethylsilsesquioxane/trimethylsiloxysilicate, silica, phenoxyethanol, polymethylsilsesquioxane, aloe barbadensis leaf juice, hdi/trimethylol hexyllactone crosspolymer, triethoxycaprylylsilane, caprylyl glycol, hydrolyzed hyaluronic acid, chlorphenesin, disteardimonium hectorite, fragrance, tocopheryl acetate, pentylene glycol, beta-glucan, amyl salicylate, tetramethyl acetyloctahydronaphthalenes.

May Contain: Titanium dioxide, iron oxides.

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LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 BEIGE 220C

Products 5

OCTINOXATE, ZINC OXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (31)

OCTINOXATE, ZINC OXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (31)

OCTINOXATE, ZINC OXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (31)

OCTINOXATE, ZINC OXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (31)

OCTINOXATE, ZINC OXIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (31)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Label CAPUCCINO 310C

INDICATIONS & USAGE SECTION

Uses

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

OTC - PURPOSE SECTION

Purpose

WARNINGS SECTION

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

OTHER SAFETY INFORMATION

Other information

INACTIVE INGREDIENT SECTION

Inactive ingredients

MedPath

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Company

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