Label: AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 13630-0143-4
- Packager: Prime Packaging, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 2, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 onto face. Spray on hands then apply to face
- do not apply in windy conditions
- use in a well-ventilated area
- 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive ingredients
SD Alcohol 40-B [Alohol Denat.], Water/Aqua/Eau, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Polyester-8, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Glycerin, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Fragrance (Parfum), Yellow 5 (CI 19140), Red 40 (CI 16035), Blue 1 (CI 42090)
- Other information
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- AUSTRALIAN GOLD INSTANT BRONZER 30 CONTINUOUS SPRAY SUNSCREEN
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25.53 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 63.825 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 42.55 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 42.55 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SUNFLOWER OIL (UNII: 3W1JG795YI) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) VINYL ACETATE (UNII: L9MK238N77) DIBUTYL MALEATE (UNII: 4X371TMK9K) KAKADU PLUM (UNII: 0ZQ1D2FDLI) TEA TREE OIL (UNII: VIF565UC2G) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color brown (Dark Amber) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0143-4 145 mL in 1 CAN; 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 Drug M020 10/31/2019 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0143) , analysis(13630-0143) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0143) , pack(13630-0143)