Label: HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-386-16
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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- 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 two 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: Ask a doctor
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Inactive Ingredients
Water, Diisopropyl Adipate, Cetearyl Alcohol, Ethylhexyl Methoxycrylene, Glycerin, Phenoxyethanol, VP/Eicosene Copolymer, Mica, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco Glucoside, Chlorphenesin, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butyrospermum Parkii (Shea) Butter, Sodium Hydroxide, Disodium EDTA, Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica
(Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Sodium Ascorbyl Phosphate, Titanium Dioxide. - Other Information
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-386 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8.5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.8 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.7 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.5 g in 100 g Inactive Ingredients Ingredient Name Strength DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) COCO GLUCOSIDE (UNII: ICS790225B) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) SHEA BUTTER (UNII: K49155WL9Y) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MANGIFERA INDICA SEED (UNII: EDO6T18WTC) PANTHENOL (UNII: WV9CM0O67Z) GUAVA (UNII: 74O70D6VG0) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) MANGO (UNII: I629I3NR86) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) ACRYLIC ACID (UNII: J94PBK7X8S) WATER (UNII: 059QF0KO0R) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) GLYCERIN (UNII: PDC6A3C0OX) BENZYL ALCOHOL (UNII: LKG8494WBH) PAPAYA (UNII: KU94FIY6JB) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-386-16 236 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2022 Labeler - Edgewell Personal Care Brands LLC (151179769)