KIDS 50 SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [CROSSING CULTURES LLC DBA GODDESS GARDEN]

KIDS 50 SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [CROSSING CULTURES LLC DBA GODDESS GARDEN]
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NDC 58479-206-02
Set ID 6a0f2536-6498-1dc7-e053-2a91aa0a57ab
Category HUMAN OTC DRUG LABEL
Packager Crossing cultures LLC dba Goddess Garden
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredient

    Titanium Dioxide 11.0%, Zinc Oxide 11.25%

  • Purpose

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

  • Do not use

    on damaged or broken skin

  • Stop use and ask doctor

    if rash occurs

  • When using this product

    keep out of eyes. Rinse with water and remove.

  • Keep out of reach of children

    If swallowed, get medical help or contact Poison Center right away.

  • Directions

    * Apply liberally 15 minutes before sun exposure.

    * Reapply:

    - After 80 minutes of swimming or sweating.

    - Immediately after towel drying.

    - 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 sun protection measures including:

    - Limit time in sun, especially from 10a.m. to 2p.m.

    - Wear long-sleeved shirts, pants, hats and sunglasses.

  • Other Information

    * Protect this product from excessive heat and direct sun.
    * Store at temperatures below 90'F.
    * May Stain some fabrics or surfaces.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Butyrospermum Parkii (Shea Butter)*, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride (Coconut Oil), Carthamus Tinctorius (Safflower) Seed Oil*, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil*, Lavandula Hybrida (Lavender) Oil*, Polyhydroxystearic Acid, Sorbitan Oleate, Stearic Acid, Tocopherol (Vitamin E), Water, Xanthan Gum

    * Certified Organic

  • Questions or Comments

    Toll-free 1-855-SAFE-SUN or www.GoddessGarden.com

  • Product Label

    Kids 50

  • INGREDIENTS AND APPEARANCE
    KIDS 50  SPF50
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58479-206-02100 g in 1 TUBE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2016
    Labeler - Crossing cultures LLC dba Goddess Garden (078444606)
    Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)

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