Label: HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70- avobenzone,homosalate,octisalate,octocrylene aerosol, spray
- NDC Code(s): 63354-083-34
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• Shake well • Hold container 4 to 6 inches from the skin to
apply • Spray liberally and spread evenly by hand 15 minutes before sun
exposure • 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
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 -
Inactive Ingredients
Alcohol Denat., Isobutane, Caprylic/Capric Triglyceride, Isododecane, Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.
- Other Information
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70
avobenzone,homosalate,octisalate,octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.8 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.7 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) DEHYDRATED ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) MINERAL OIL (UNII: T5L8T28FGP) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PAPAYA (UNII: KU94FIY6JB) MANGO (UNII: I629I3NR86) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GUAVA (UNII: 74O70D6VG0) ISOBUTANE (UNII: BXR49TP611) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-083-34 170 g in 1 CAN; 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)