Label: AUSTRALIAN GOLD SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 58443-0375-4
- 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 January 5, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor
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Inactive Ingredients
Aloe Barbadensis Leaf Juice, Water/Aqua/Eau, Cocos Nucifera (Coconut) Oil, Glycerin, Tapioca Starch, VP/Acrylates/Lauryl Methacrylate Copolymer, Phenoxyethanol, Acrylic Acid/VP Crosspolymer, Fragrance (Parfum), Sodium Hydroxide, Caprylyl Glycol, Polyacrylate-13, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyisobutene, Polymethylsilsesquioxane, Polysorbate 20
- Other Information
- Questions or comments?
- Australian Gold Plant Based Lotion Sunscreen SPF 30
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0375 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.67 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 74.18 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49.45 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.45 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) STARCH, TAPIOCA (UNII: 24SC3U704I) POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY) COCONUT OIL (UNII: Q9L0O73W7L) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) Product Characteristics Color white (White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0375-4 177 mL in 1 TUBE; Type 0: Not a Combination Product 12/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2020 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(58443-0375) , label(58443-0375) , analysis(58443-0375) , pack(58443-0375)
