Label: HAWAIIAN TROPIC ISLAND TANNING BROAD SPECTRUM SPF 25- avobenzone,homosalate,octisalate,octocrylene oil
- NDC Code(s): 63354-521-16
- Packager: Edgewell Personal Care Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 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
-
Inactive ingredients
Mineral Oil, Ethylhexyl Palmitate, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Aloe Barbadensis Leaf Extract, Red 17, Yellow 11
- Other information
- Questions or Comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC ISLAND TANNING BROAD SPECTRUM SPF 25
avobenzone,homosalate,octisalate,octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-521 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) ARGININE (UNII: 94ZLA3W45F) TARTARIC ACID (UNII: W4888I119H) CARROT (UNII: L56Z1JK48B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GUAVA (UNII: 74O70D6VG0) .BETA.-CAROTENE (UNII: 01YAE03M7J) HISTIDINE (UNII: 4QD397987E) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) D&C YELLOW NO. 11 (UNII: 44F3HYL954) CORN OIL (UNII: 8470G57WFM) TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X) MANGO (UNII: I629I3NR86) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) PAPAYA (UNII: KU94FIY6JB) COCONUT OIL (UNII: Q9L0O73W7L) COCOA BUTTER (UNII: 512OYT1CRR) ALOE VERA LEAF (UNII: ZY81Z83H0X) D&C RED NO. 17 (UNII: ND733RX3JN) ETHYLHEXYL PALMITATE (UNII: 2865993309) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SOYBEAN OIL (UNII: 241ATL177A) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-521-16 227 g in 1 BOTTLE; Type 0: Not a Combination Product 11/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/18/2019 Labeler - Edgewell Personal Care Brands, LLC (151179769)
