Label: HAWAIIAN TROPIC- avobenzone, homosalate, octocrylene spray
- NDC Code(s): 63354-071-12
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
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Directions
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 or sweating • 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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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone, homosalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ALCOHOL (UNII: 3K9958V90M) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-071-12 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/05/2023 Labeler - Edgewell Personal Care Brands LLC (151179769)