Label: HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50- zinc oxide lotion

  • NDC Code(s): 72096-101-01, 72096-101-02
  • Packager: Kokua Sun Care
  • 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 June 27, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Zinc Oxide 25% 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 caused by the sun.
  • 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 or broken skin
    • When using this product keep out of eyes
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously 15 minutes before sun exposure
    • Reapply:
    • After 80 minutes if 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 am-2pm.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.
    • Children under 6 months: ask a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Macadamia Ternifolia Seed (Macadamia Nut) Oil, Aleurites Moluccana Seed (Kukui nut) oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Glycerin, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, KonaRed Hawaiian Coffee Fruit Extract, Morinda Citrifolia Fruit Juice (Noni), Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Prunus Armeniaca (Apricot) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Santalum Album (Sandalwood) Extract, Butter Extract, Coffea Arabica (Coffee) Leaf/seed Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

  • PRINCIPAL DISPLAY PANEL

    Hawaiian Natural Zinc Sunscreen

    Broad Spectrum SPF 50

    Water Resistant 80 minutes

    89 mL / 3 FL OZ

    Tube

    box

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN NATURAL ZINC SUNSCREEN SPF 50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72096-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    COCONUT (UNII: 3RT3536DHY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    VANILLA (UNII: Q74T35078H)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    APRICOT (UNII: 269CJD5GZ9)  
    MUSKMELON (UNII: ZV095H5633)  
    KAOLIN (UNII: 24H4NWX5CO)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)  
    NONI FRUIT JUICE (UNII: 6ULF85Z07J)  
    ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)  
    RICE BRAN (UNII: R60QEP13IC)  
    ROSEMARY (UNII: IJ67X351P9)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    BANANA (UNII: 4AJZ4765R9)  
    APPLE (UNII: B423VGH5S9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SANDALWOOD (UNII: 3641YW25N2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72096-101-0189 g in 1 BOX; Type 0: Not a Combination Product02/10/2018
    2NDC:72096-101-0230 g in 1 BOX; Type 0: Not a Combination Product06/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/10/2018
    Labeler - Kokua Sun Care (081062410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vege Labs LLC.117878620manufacture(72096-101)
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