Label: AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN- avobenzone, and octocrylene spray
- NDC Code(s): 58443-0278-4
- 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 April 24, 2020
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- Official Label (Printer Friendly)
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INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Caramel, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water
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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
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
- Purpose
- Uses
- Active Ingredients
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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
- Other Information
- Questions or Comments?
- Australian Gold INSTANT BRONZER SPF 4 BROAD SPECTRUM Sunscreen
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN
avobenzone, and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0278 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 FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) KAKADU PLUM (UNII: 0ZQ1D2FDLI) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) HYPROMELLOSES (UNII: 3NXW29V3WO) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER SEED (UNII: R9N3379M4Z) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F) 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) Product Characteristics Color brown (Caramel color) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0278-4 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/16/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0278) , manufacture(58443-0278) , label(58443-0278) , analysis(58443-0278)
