Label: HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30- avobenzone,homosalate,octisalate,octocrylene liquid
- NDC Code(s): 63354-197-21
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
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 October 17, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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 -
Inactive Ingredients
Water, Silica,
Propylene Glycol, Cetyl Dimethicone,
Phenoxyethanol, Mica, Sodium
Polyacrylate, Acrylates/C12-22 Alkyl
Methacrylate Copolymer, Caprylyl
Glycol, Fragrance, Chlorphenesin,
Glycerin, Disodium EDTA, Aloe
Barbadensis Leaf Juice, Sodium
Hyaluronate, Hibiscus Sabdariffa
Flower Extract, Carica Papaya (Papaya)
Fruit Extract, Mangifera Indica (Mango)
Fruit Extract, Passiflora Incarnata Fruit
Extract, Plumeria Acutifolia Flower
Extract, Psidium Guajava Fruit Extract,
Titanium Dioxide. - Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30
avobenzone,homosalate,octisalate,octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-197 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) PAPAYA (UNII: KU94FIY6JB) MICA (UNII: V8A1AW0880) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) MANGO (UNII: I629I3NR86) EDETATE DISODIUM (UNII: 7FLD91C86K) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-197-21 41 g in 1 TUBE; 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 not final part352 10/01/2022 Labeler - Edgewell Personal Care Brands LLC (151179769) Establishment Name Address ID/FEI Business Operations Playtex Manufacturing Inc. (Ormond Beach) 963501502 manufacture(63354-197)
HAWAIIAN