Label: BLACK GIRL SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene gel
- NDC Code(s): 58443-0629-3
- 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 August 4, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately 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 and sunglasses
children under 6 months: Ask a doctor.
- INACTIVE INGREDIENT
- Other information
- PRINCIPAL DISPLAY LABEL - 1.7oz Black Girl Sunscreen Broad Spectrum SPF 45 Ultra Sheer Sunscreen Gel
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INGREDIENTS AND APPEARANCE
BLACK GIRL SUNSCREEN SPF 45
avobenzone, homosalate, octisalate, octocrylene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0629 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 95 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 47.5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 95 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) COCONUT OIL (UNII: Q9L0O73W7L) SHEA BUTTER (UNII: K49155WL9Y) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SQUALANE (UNII: GW89575KF9) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0629-3 50 mL in 1 TUBE; Type 0: Not a Combination Product 08/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/04/2023 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0629) , label(58443-0629) , analysis(58443-0629) , pack(58443-0629)