Label: AUSTRALIAN GOLD BOTANICAL SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 13630-0110-4
- Packager: Prime Packaging Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 2, 2024
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- 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 into face. Spray on hands then apply to face
- do not apply in windy conditions
- use in 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
- Question or comments?
- Botanical Sunscreen Broad Spectrum SPF 30 Natural
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BOTANICAL SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 26.04 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 86.8 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 43.4 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 23.87 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALCOHOL (UNII: 3K9958V90M) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) KAKADU PLUM (UNII: 0ZQ1D2FDLI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0110-4 177 mL in 1 CAN; Type 0: Not a Combination Product 07/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/15/2016 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0110) , analysis(13630-0110) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0110) , label(13630-0110)