Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 4- avobenzone, octocrylene oil
- NDC Code(s): 58443-0457-4
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 3, 2024
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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 cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging
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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 the 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
Acetylated Lanolin Alcohol, Aleurites Moluccana Seed Oil, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidene-Malonate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer
- Other information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BROAD SPECTRUM SPF 4
avobenzone, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0457 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 9.02 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) KAKADU PLUM (UNII: 0ZQ1D2FDLI) CARROT SEED OIL (UNII: 595AO13F11) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ACETATE (UNII: 4Q43814HXS) ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SUNFLOWER OIL (UNII: 3W1JG795YI) ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H) TEA TREE OIL (UNII: VIF565UC2G) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) TRICAPRIN (UNII: O1PB8EU98M) KUKUI NUT OIL (UNII: TP11QR7B8R) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0457-4 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/22/2020 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0457) , pack(58443-0457) , manufacture(58443-0457) , analysis(58443-0457)