Label: HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF30- titanium dioxide, zinc oxide oil

  • NDC Code(s): 63354-603-12
  • 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 December 12, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Titanium Dioxide 4.3%, Zinc Oxide 6.0%

  • Purpose

    sunscreen

  • Uses

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

    May stain some fabrics and surfaces.

  • 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

  • Directions

    • shake well • 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 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 longsleeved shirts, pants, hats, and
    sunglasses • children under 6 months: Ask a doctor.

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate,
    Glycerin, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone,
    VP/Eicosene Copolymer, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Glyceryl Stearate,
    Polyhydroxystearic Acid, Sodium Chloride, Phenoxyethanol, Stearalkonium Bentonite,
    Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Ethylhexylglycerin, Aleurites
    Moluccanus Seed Oil, Triethoxycaprylylsilane, Mica, Titanium Dioxide, Psidium Guajava
    Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract,
    Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya)
    Fruit Extract, Iron Oxides.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions or Comments?

    1-800-NO UV RAY, Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    HAWAIIAN

    TROPIC

    SUNSCREEN LOTION

    MINERAL

    SKIN NOURISHING MILK

    COCONUT OIL

    30

    CRUELTY FREE | VEGAN
    BROAD SPECTRUM SPF30 UVA/UVB

    3.4 FL. OZ (100mL)

    label

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF30 
    titanium dioxide, zinc oxide oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.3 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PAPAYA (UNII: KU94FIY6JB)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    MANGO (UNII: I629I3NR86)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    WATER (UNII: 059QF0KO0R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GUAVA (UNII: 74O70D6VG0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-603-12100 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2022
    Labeler - Edgewell Personal Care Brands LLC (151179769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Playtex Manufacturing Inc. (Ormond Beach)963501502manufacture(63354-603)