Label: SPF-30 SPORT MOISTURIZER- zinc oxide lotion

  • 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 September 5, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see other information), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    • When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts.

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

    Due to the nature of mineral formulations, separation may occur. Shake tube before use. Apply a smooth, even layer to face, neck and top of hands before sun exposure and as needed. Children under 6 months of age, ask a doctor.

  • Other Information

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures incluing:

    Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    Organic juices of aloe barbadensis (organic aloe juice)1, pyrus malus (organic apple juice)1, vitis vinifera (organic white grape juice)1, cocos nucifera (organic coconut oil)1, caprylic/capric triglycerides, sorbitan stearate, ricinus communis (castor seed oil), hydrogenated methyl abietate, polyglyceryl-10 laurate, magnesium sulfate, helianthus annuus (organic sunflower seed oil)1, simmondsia chinensis (organic jojoba seed oil)1, tocopherol (Vitamin E), magnesium ascorbyl phosphate (Vitamin C), citrus limonum (lemon extract), iron oxides, phenethyl alcohol, ethylhexylglycerin, citrus reticulata (mandarin) & citrus aurantium (petitgrain) pure essential oils.

    1
    certified organic ingredient
  • Questions?

    www.juicebeauty.com

  • PRINCIPAL DISPLAY PANEL - 110 mL Tube Label

    SPORT

    juice
    BEAUTY    ®
    THE ORGANIC SOLUTION™

    SPF 30 Sport
    Moisturizer

    MADE WITH
    CERTIFIED
    ORGANIC
    INGREDIENTS

    Water Resistant
    (80 minutes)
    Antioxidant Rich

    3.75 fl oz e 110 mL

    Principal Display Panel - 110 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    SPF-30 SPORT MOISTURIZER 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55165-0104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    apple juice (UNII: 9871T0PD5P)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    coconut oil (UNII: Q9L0O73W7L)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    polyglyceryl-10 laurate (UNII: MPJ2Q8WI8G)  
    magnesium sulfate (UNII: DE08037SAB)  
    sunflower oil (UNII: 3W1JG795YI)  
    jojoba oil (UNII: 724GKU717M)  
    tocopherol (UNII: R0ZB2556P8)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ferric oxide red (UNII: 1K09F3G675)  
    phenylethyl alcohol (UNII: ML9LGA7468)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    mandarin oil (UNII: NJO720F72R)  
    citrus aurantium leafy twig oil (UNII: 5K6H1IMT3D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55165-0104-1110 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/03/2012
    Labeler - Juice Beauty (263151582)
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