Label: HAWAIIAN TROPIC MATTE EFFECT MINERAL ENRICHED SUNSCREEN SPF 50- homosalate,octisalate,octocrylene,zinc oxide lotion

  • NDC Code(s): 63354-542-24
  • Packager: Edgewell Personal Care Brands, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2023

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  • Active Ingredients

    Homosalate 8.0%, Octisalate 4.5%, Octocrylene 5.7%, Zinc Oxide 7.3%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use

    on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

    If product IS swallowed, get medical help or contact a Poison Control Center right away.

  • May stain

    some fabrics.

  • 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

    Water, Isohexadecane, Cetyl Alcohol, Glycerin, VP/Eicosene Copolymer, PEG-100 Stearate, Glyceryl Stearate, Alcohol Denat., Silica, Phenoxyethanol, Xanthan Gum, Polyhydroxystearic Acid, Fragrance, Chlorphenesin, Triethoxycaprylylsilane, Disodium EDTA, Sea Salt, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract.

  • Other information

    protect this product from excessive heat and direct sun

  • Questions or comments?

    Call 1-800-NO UV RAY, Mon-Fri

  • Principal Display Panel

    HAWAIIAN

    Tropic®

    Matte

    EFFECT

    MINERAL ENRICHED SUNSCREEN LOTION SPF 50+

    Non-Greasy & Lightweight

    50+

    SPF 50+ Broad Spectrum

    UVA & UVB PROTECTION

    RECOMMENDED

    SKIN

    CANCER

    FOUNDATION

    DAILY USE

    Recommended as an

    effective broad spectrum

    sunscreen

    Reef Friendly*

    with naturally sourced

    sea minerals

    6 FL.OZ. (177 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC MATTE EFFECT MINERAL ENRICHED SUNSCREEN SPF 50 
    homosalate,octisalate,octocrylene,zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-542
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.75 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.395 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    MANGO (UNII: I629I3NR86)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GUAVA (UNII: 74O70D6VG0)  
    PAPAYA (UNII: KU94FIY6JB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-542-246 g in 1 TUBE; Type 0: Not a Combination Product08/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/14/2019
    Labeler - Edgewell Personal Care Brands, LLC (151179769)