Label: BLACK GIRL SUNSCREEN SPF 50 BROAD SPECTRUM- avobenzone, homosalate, octisalate lotion
- NDC Code(s): 58443-0625-4
- 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 July 18, 2023
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- 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, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats & sunglasses
- children under 6 months: Ask a doctor
-
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Seed Oil, Disodium EDTA, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Lecithin, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Tocopheryl Acetate, Water
- Other Information
- Black Girl Sunscreen Kids Moisturizing Sunscreen Lotion for Face and Body 50 Broad Spectrum SPF 50
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INGREDIENTS AND APPEARANCE
BLACK GIRL SUNSCREEN SPF 50 BROAD SPECTRUM
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0625 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28.77 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 143.85 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 47.95 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) AVOCADO OIL (UNII: 6VNO72PFC1) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARROT SEED OIL (UNII: 595AO13F11) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUNFLOWER SEED (UNII: R9N3379M4Z) HYPROMELLOSES (UNII: 3NXW29V3WO) JOJOBA OIL (UNII: 724GKU717M) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER 980 (UNII: 4Q93RCW27E) SODIUM HYDROXIDE (UNII: 55X04QC32I) SHEA BUTTER (UNII: K49155WL9Y) CHAMOMILE (UNII: FGL3685T2X) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 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:58443-0625-4 178 mL in 1 TUBE; Type 0: Not a Combination Product 04/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/22/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(58443-0625) , analysis(58443-0625) , pack(58443-0625) , label(58443-0625)