MAUI SURFER HONEY NATURAL SUNSCREEN (ZINC OXIDE) LOTION [HAWAIIAN CLASSIC PERFUMES, INC.]

MAUI SURFER HONEY NATURAL SUNSCREEN (ZINC OXIDE) LOTION [HAWAIIAN CLASSIC PERFUMES, INC.]
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NDC 58918-001-02
Set ID 50393ea8-09f8-4e4b-b15d-c77c0c557ef4
Category HUMAN OTC DRUG LABEL
Packager Hawaiian Classic Perfumes, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Maui Surfer Honey Natural Sunscreen Lotion SPF 30

    SH front image

    (Front Label:)

    Maui Surfer Honey - Natural Sunscreen - Broad Spectrum - SPF 30 - Water Resistant 80 Minutes - Eco/Reef Friendly - 3 fl oz - 90 mL

    SH back image

    (Back Label:)

    Drug Facts

    Active Ingredient - Purpose

    Zinc Oxide (20%) .......................................................................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. 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

    *apply liberally 15 minutes before sun exposure

    *re-apply:

    *after 80 minutes of swimming or sweating

    *immediately after towel drying AND at least every 2 hours.

    *Sun Protection Measures. Spending time in the sun increases your riskof 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-sleeve shirts, pants, hats, and sunglasses

    *children under 6 months: Ask a doctor.

    Inactive Ingredients: Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Castor Oil, Ethyl Vanillin, Honey, Hydrogenated Methyl Abietate, Jojoba Oil, Magnesium Sulfate, Olive Oil, Orange Oil (Steam Distilled), Polyaminopropyl Biguanide, Polyglycerol-10 Laurate, Sorbitan Stearate, Sunflower Oil, Tocopherols (Vitamin E), Water.

    Other Information: Contains no nano particles.

    Protect this product from excessive heat and direct sun.

    Maui Natural Organics

    375 W. Kuiaha, No. 39 — Haiku, Maui 96708

    Tel 808 575 2100 — www.MauiNaturalOrganics.com

    7 54220 70950 1

  • INGREDIENTS AND APPEARANCE
    MAUI SURFER HONEY NATURAL SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58918-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    ORANGE OIL, DISTILLED (UNII: H4QNH2ZN7A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58918-001-0290 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/07/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/07/2014
    Labeler - Hawaiian Classic Perfumes, Inc. (103409512)

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