Label: HAWAIIAN NATURAL ZINC SUNSCREEN BROAD SPECTRUM TINTED SPF 30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 18, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Non Nano Zinc Oxide 18%

    Purpose

    Sunscreen

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warnings

    • for external use only
    • Do not use on damaged skin
    • When using this product keep out of eyes. Rinse with water to remove
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously 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 10am - 2pm
        • Wear long-sleeve shirts, pants, hats, and sunglasses
        • Children under 6 months: ask a doctor
  • INACTIVE INGREDIENT

    Water (Aqua), Aloe Barbadensis Leaf Juice, Coco-caprylate/Caprate, Glycerin, Macademia (Ternifolia) Seed Oil, Kukui Seed(Aleurites Moluccana) Oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Hydrogenated Methyl Abietate, Magnesium Sulfate, Galactoarabinan, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Propanediol, Polyglyceryl-2 Stearate, Caprylic/Capric Triglyceride, Noni (Morinda Citrifola) Fruit Extract, Spirulina (Arthrospira Platensis), Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Coffea Arabica (Coffee) Leaf/Seed Extract, Vanilla planifolia Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Cinnamomium Zeylanicum Bark Extract, Kaolin, Hydrogenated Vegetable Oil, Helianthus Annuus (Sunflower) Seed Oil, Plumeria Alba Flower Extract, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Levulinate, Sodium Anisate, Iron oxides

  • PRINCIPAL DISPLAY PANEL

    Kokua Sun Care

    Tinted SPF 30

    Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 30

    80 Minutes

    Water Resistant

    89 ML/ 3 FL OZ

    kokua tinted SPF 30

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN NATURAL ZINC SUNSCREEN BROAD SPECTRUM TINTED SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72096-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    KAOLIN (UNII: 24H4NWX5CO)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    VANILLA BEAN (UNII: Q74T35078H)  
    APRICOT (UNII: 269CJD5GZ9)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    NONI FRUIT (UNII: 7829X3G2X5)  
    ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)  
    ROSEMARY (UNII: IJ67X351P9)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72096-102-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02004/18/2023
    Labeler - Kokua Sun Care (081062410)
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