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

MAUI NATURALS ALL NATURAL SUNSCREEN (ZINC OXIDE) LOTION [HAWAIIAN CLASSIC PERFUMES, INC.]
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NDC 58918-002-02
Set ID 1f9016b3-c773-4f02-a785-f712ee8c320b
Category HUMAN OTC DRUG LABEL
Packager Hawaiian Classic Perfumes, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Maui Naturals All Natural Sunscreen Lotion SPF 30

    front

    (Front Label:)

    Broad Spectrum - Maui Naturals - All Natural Sunscreen SPF 30 - Eco/Reef Friendly - no avo/oxybenzones - no petrochemicals - no nano particles - water resistant - 80 Min - with Maui Grown Essential Oils - 3 ounces /90 mL

    back photo

    (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 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 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, Hydrogenated Methyl Abietate, Jojoba Oil, Lemongrass Essential Oil, Magnesium Sulfate, Olive Oil, Polyaminopropyl Biguanide, Polyglycerol-10 Laurate, Rosemary Essential Oil, 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 70941 9

  • INGREDIENTS AND APPEARANCE
    MAUI NATURALS ALL NATURAL SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58918-002
    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
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58918-002-0290 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/10/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/10/2014
    Labeler - Hawaiian Classic Perfumes, Inc. (103409512)

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