Label: AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 6 SUNSCREEN- avobenzone, octocrylene spray
- NDC Code(s): 58443-0642-4
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only
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Directions
- shake well before use
- apply liberally 15 minutes before sun exposure and rub into skin
- hold container 4 to 6 inches from skin to apply
- do not spray directly into face. Spray on hands then apply to face
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor
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INACTIVE INGREDIENTS
Water, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Butylphthalimide, Caramel, Phenoxyethanol, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isopropylphthalimide, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Trimethoxysiloxysilicate, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Sodium Hydroxide, Propylene Glycol, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride
- Other Information
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- Australian Gold INSTANT BRONZER SPF 4 BROAD SPECTRUM Sunscreen
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 6 SUNSCREEN
avobenzone, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0642 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYPROMELLOSES (UNII: 3NXW29V3WO) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER SEED (UNII: R9N3379M4Z) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) TEA TREE OIL (UNII: VIF565UC2G) OLIVE OIL (UNII: 6UYK2W1W1E) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CARAMEL (UNII: T9D99G2B1R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) Product Characteristics Color brown (Caramel) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0642-4 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/18/2022 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0642) , manufacture(58443-0642) , label(58443-0642) , analysis(58443-0642)
