Label: HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion

  • NDC Code(s): 63354-421-12
  • Packager: Edgewell Personal Care Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Active Ingredients

    Zinc Oxide 15.0%

  • 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

  • Warnings

    • For external use only.

    Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

    May stain some fabrics.

    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, Isododecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Fragrance, Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Tocopheryl Acetate, Sodium Citrate, Aloe Barbadensis Leaf Juice, Glycerin, Mica, Titanium Dioxide, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava 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

    NEW
    HAWAIIAN
    TROPIC(R)
    MINERAL
    SKIN NOURISHING
    MILK
    30
    SUNSCREEN BROAD SPECTRUM SPF30
    UVA/UVB
    OXYBENZONE & OCTINOXATE FREE
    CRUELTY-FREE
    SHAKE WELL BEFORE USE
    3.4 FL. OZ. (100 mL)

    63354-421-12 label

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK SUNSCREEN BROAD SPECTRUM SPF 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PAPAYA (UNII: KU94FIY6JB)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    MANGO (UNII: I629I3NR86)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    GUAVA (UNII: 74O70D6VG0)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-421-12100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2021
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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