Label: AUSTRALIAN GOLD INSTANT BRONZER 15 SUNSCREEN- avobenzone, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0280-4 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
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 12, 2021
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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 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
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Inactive Ingredients
Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Glycerin, Butylphthalimide, Caramel, Polyethylene, Isopropylphthalimide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Sodium Hydroxide, Carbomer, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Allantoin, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Fragrance(Parfum), Phenoxyethanol, Ethylhexylglycerin
- Other information
- Questions or comments?
- Australian Gold Instant Bronzer 15 Lotion Sunscreen
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD INSTANT BRONZER 15 SUNSCREEN
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20.36 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.9 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20.36 mg in 1 mL Inactive Ingredients Ingredient Name Strength N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) KAKADU PLUM (UNII: 0ZQ1D2FDLI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALLANTOIN (UNII: 344S277G0Z) TEA TREE OIL (UNII: VIF565UC2G) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CARAMEL (UNII: T9D99G2B1R) CARBOMER 980 (UNII: 4Q93RCW27E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) HYPROMELLOSES (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) OLIVE OIL (UNII: 6UYK2W1W1E) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCOA BUTTER (UNII: 512OYT1CRR) 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:58443-0280-4 237 mL in 1 TUBE; Type 0: Not a Combination Product 10/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/31/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0280) , manufacture(58443-0280) , label(58443-0280) , analysis(58443-0280)