MedPath

Hello Bello Mineral Sunscreen SPF 50

Mineral Sunscreen Lotion + ANTIOXIDANTS SPF50

Approved
Approval ID

34bb8560-8223-e810-e063-6394a90ad45d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 2025

Manufacturers
FDA

Hello Bello

DUNS: 081135707

Products 1

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

Zinc Oxide Titanium Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73418-106
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide Titanium Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (33)

OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HEXYL LAURATEInactive
Code: 4CG9F9W01Q
Classification: IACT
POLYGLYCERYL-4 ISOSTEARATEInactive
Code: 820DPX33S7
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
ZINC OXIDEActive
Quantity: 100 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, D-Inactive
Code: A7E6112E4N
Classification: IACT
ALUMINAInactive
Code: LMI26O6933
Classification: IACT
ETHYLHEXYL STEARATEInactive
Code: EG3PA2K3K5
Classification: IACT
VP/HEXADECENE COPOLYMERInactive
Code: KFR5QEN0N9
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
CETYL DIMETHICONE 25Inactive
Code: U4AS1BW4ZB
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)Inactive
Code: 035JKJ76MT
Classification: IACT
DIMETHICONE 100Inactive
Code: RO266O364U
Classification: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HM
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
METHYL GLUCOSE DIOLEATEInactive
Code: FA9KFJ4Z6P
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EUPHORBIA CERIFERA (CANDELILLA) WAXInactive
Code: WL0328HX19
Classification: IACT
PEG-7 HYDROGENATED CASTOR OILInactive
Code: WE09129TH5
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)Inactive
Code: 25LXE464L2
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 80 mg in 1 g
Code: 15FIX9V2JP
Classification: ACTIB
APHANIZOMENON FLOSAQUAEInactive
Code: 49VG1X560X
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/9/2025

Sunscreen Label

HB Mineral Sunscreen Tube 050925

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/9/2025

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/9/2025

Other Information

Protect this product from excessive heat and direct sun

Avoid long-term exposure storage above 40°C (104°F)

May stain some fabrics

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/9/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/9/2025

Active Ingredients

Titanium Dioxide 8%

Zinc Oxide 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/9/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 5/9/2025

Warnings

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 5/9/2025

Directions

Shake well before use

Apply liberally and spread evenly by hand 15 minutes before sun exposure

Reapply:

after 80 minutes of swimming or sweating immediately after towel use
at least every 2 hours

Sun Protection Measures

Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limiting time in the sun, especially from 10a.m. - 2p.m.
Wearing long-sleeved shirts, pants, hats and sunglasses

Children under six months: Ask a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/9/2025

Inactive Ingredients

1,2-Hexanediol, Alumina, Aluminum Stearate, Aphanizomenon Flos-aquae Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Sodium Benzoate, Tocopherol (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/9/2025

Questions?

Support@HelloBello.com

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/9/2025

Keep out of reach of children

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Hello Bello Mineral Sunscreen SPF 50 - FDA Drug Approval Details