OCEAN FRIENDLY SUNSCREEN SPF30 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LEMONGRASS SPA PRODUCTS LLC]

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OCEAN FRIENDLY SUNSCREEN SPF30 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LEMONGRASS SPA PRODUCTS LLC]
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NDC 70553-731-01, 70553-731-02
Set ID 56f21c10-095b-4b15-9998-93887f58e2a4
Category HUMAN OTC DRUG LABEL
Packager Lemongrass Spa Products LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide (6.0%)
    Zinc Oxide (6.0%)

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures. 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.

    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 40 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 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

    Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Glucoside, Cetearly Olivate, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Lecithin, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Tocopherol (Vitamin E), Xanthan Gum

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    LabelLabe3

  • INGREDIENTS AND APPEARANCE
    OCEAN FRIENDLY SUNSCREEN SPF30 BROAD SPECTRUM 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70553-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCONUT (UNII: 3RT3536DHY)  
    EUCALYPTUS GUM (UNII: 72T9EZC2VX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70553-731-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/07/2017
    2NDC:70553-731-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2016
    Labeler - Lemongrass Spa Products LLC (069703885)
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