Label: HAWAIIAN TROPIC- avobenzone,homosalate,octocrylene spray
- NDC Code(s): 63354-712-12
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 4, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• Shake well • Hold container 4 to 6 inches from the skin to apply. Don’t spray directly into face. Apply on hand then apply to face. Spray evenly and liberally on your skin. Apply 15 minutes before sun exposure. Reapply throughout the day • at least every 2 hours, • after 80 minutes of swimming orsweating • immediately after towel drying • 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, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Oryza Sativa (Rice) Starch, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Glycerin, Sodium Polyacrylate, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract.
- Other Information
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-712 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength PEG-100 STEARATE (UNII: YD01N1999R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GUAVA (UNII: 74O70D6VG0) EDETATE DISODIUM (UNII: 7FLD91C86K) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) MANGO (UNII: I629I3NR86) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) WATER (UNII: 059QF0KO0R) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) STARCH, RICE (UNII: 4DGK8B7I3S) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PAPAYA (UNII: KU94FIY6JB) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-712-12 62 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2023 Labeler - Edgewell Personal Care Brands LLC (151179769)
