Label: BLACK GIRL SUNSCREEN SPF 50 BROAD SPECTRUM- homosalate, octocrylene, octisalate, zinc oxide lotion
- NDC Code(s): 58443-0509-3
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 14, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply
- after 80 minutes of swimming or sweating
- inmediately after towel drying
- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures, including:
- limit time in the sun, specially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats & sunglasses.
- children under 6 months: Ask a doctor.
-
Inactive ingredients
Acrylic Acid/VP Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Seed Oil, Ethyl Ferulate, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Olus Oil, Persea Gratissima (Avocado) Oil, Pongamia Pinnata Seed Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Tetrasodium Glutamate Diacetate , Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Acrylates/Lauryl Methacrylate Copolymer, Water
- Other Information
- Black Girl Sunscreen Mineral Combo Sunscreen Lotion for Face & Body Broad Spectrum SPF 50
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INGREDIENTS AND APPEARANCE
BLACK GIRL SUNSCREEN SPF 50 BROAD SPECTRUM
homosalate, octocrylene, octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0509 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CORN OIL (UNII: 8470G57WFM) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LAVENDER OIL (UNII: ZBP1YXW0H8) ETHYL FERULATE (UNII: 5B8915UELW) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) MILLETTIA PINNATA SEED (UNII: C2BRV53B1V) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) AVOCADO OIL (UNII: 6VNO72PFC1) CARROT SEED OIL (UNII: 595AO13F11) WATER (UNII: 059QF0KO0R) SUNFLOWER SEED (UNII: R9N3379M4Z) JOJOBA OIL (UNII: 724GKU717M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM HYDROXIDE (UNII: 55X04QC32I) SHEA BUTTER (UNII: K49155WL9Y) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Product Characteristics Color white (White to off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0509-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 11/24/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/24/2021 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(58443-0509) , analysis(58443-0509) , pack(58443-0509) , label(58443-0509)