Label: BROAD SPECTRUM SPF15 VERY WATER RESISTANT (80 MINUTES) SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate cream
- NDC Code(s): 53675-206-00, 53675-206-01
- Packager: Aruba Aloe Balm NV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 22, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- apply generously 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 value 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 of age: Ask a doctor.
- Other Information
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Inactive ingredients
Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.
- Package Labeling:53675-206-00
- Package Labeling:53675-206-01
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF15 VERY WATER RESISTANT (80 MINUTES) SUNSCREEN
avobenzone, homosalate, octocrylene, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53675-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 73.4 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 PHOSPHATE (UNII: 921FTA1500) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) JOJOBA OIL (UNII: 724GKU717M) COCONUT OIL (UNII: Q9L0O73W7L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL LAURATE (UNII: Y98611C087) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53675-206-00 59 mL in 1 TUBE; Type 0: Not a Combination Product 06/02/2023 2 NDC:53675-206-01 177 mL in 1 TUBE; Type 0: Not a Combination Product 06/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/02/2023 Labeler - Aruba Aloe Balm NV (855442273)
