Label: SPF 30 MINERAL SUN STICK- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

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 August 23, 2019

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients: 

    Zinc Oxide 18.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • WARNINGS

    Warnings
    • For External Use Only 
  • DO NOT USE

    • Do not use on damaged or broken skin
  • STOP USE

    Stop use and as a doctor if • rash occurs

  • WHEN USING

    When using this product • Keep out of eyes.  Rinse well with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions •Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating

    • Reapply at least every 2 hours
    • Children under 6 months of age: Ask a doctor

    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 value of 15 or higher and
    other protection measures including:
    • limit time in the sun, especially from 10a.m. - 2p.m.
    • wear long sleeved shirts, pants, hat, and sunglasses.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Sunflower Seed Oil*, Beeswax*, Olive Oil*, Tocopherol,

    aloe vera leaf extract, canola oil.  *Organic Ingredient

  • OTHER SAFETY INFORMATION

    Other Information:  Protect this product from excessive heat and direct sun.

  • Product Package Labeling

    ◀ PEEL HERE FOR DRUG FACTS 

    Broad Spectrum

    SPF 30 Mineral Sun Stick

    Made in the USA

    Net Wt. 0.6.oz.

    Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403

    L000000

    SAFETY SEAL

    SunStick

    res

  • INGREDIENTS AND APPEARANCE
    SPF 30 MINERAL SUN STICK 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0848
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.06 g  in 17 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0848-117 g in 1 TUBE; Type 0: Not a Combination Product08/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/21/2019
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
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