Label: HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN FACE BROAD SPECTRUM SPF 30- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-581-11
- Packager: Edgewell Personal Care Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 13, 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 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 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, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, Benzyl Alcohol, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Fragrance, Polysorbate 60, Xanthan Gum, Coco-Glucoside, Disodium EDTA, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC SILK HYDRATION SUNSCREEN FACE BROAD SPECTRUM SPF 30
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-581 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 60 (UNII: CAL22UVI4M) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) PAPAYA (UNII: KU94FIY6JB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) XANTHAN GUM (UNII: TTV12P4NEE) CHLORPHENESIN (UNII: I670DAL4SZ) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO GLUCOSIDE (UNII: ICS790225B) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOHEXADECANE (UNII: 918X1OUF1E) MICA (UNII: V8A1AW0880) PANTHENOL (UNII: WV9CM0O67Z) GUAVA (UNII: 74O70D6VG0) MANGO (UNII: I629I3NR86) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMINO ACIDS, SILK (UNII: V0L00EX1IA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-581-11 48.19 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/23/2020 Labeler - Edgewell Personal Care Brands, LLC (151179769)
