Label: GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide spray
GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 12, 2016

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 6.4% Zinc Oxide 6.0%

    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.

    Stop use and ask a 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 a Poison Center right away.

  • Directions

    Hold container 4 to 6 inches from skin to apply. • Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Should spray white lotion. • Rub in. • Shake well. Should spray white lotion. Rub in. • Do not spray directly into face. Spray on hands and apply to face. • Do not apply in windy conditions. • Use in a well ventilated area. • Avoid inhaling or exposing others to spray. • Reapply: • 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 sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am to 2pm. • Wear long-sleeved shirts, pants, hats and sunglasses. • For use on children less than 6 months of age, consult a doctor.

  • 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, 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 (Lavandin) Oil*, Polyglyceryl-10 Decaoleate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol (Vitamin E), Water, Xanthan Gum *Certified Organic

  • Questions or Comments

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

  • goddess garden

    After discovering our daughter was sensitive to synthetic chemicals, we were inspired to create better alternatives using organic, plant-based ingredients. Our sunscreens go on sheer and provide powerful protection that is safe for people and the planet. Paul and Nova, Founders Reef Safe Non-Nano Biodegradable Non-GMO

  • Product Label

    Kids8ozGGKids236mL

  • INGREDIENTS AND APPEARANCE
    GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN  SPF 30
    titanium dioxide, zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.4 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58479-043-00227 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/17/2016
    GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN  SPF 30
    titanium dioxide, zinc oxide aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.4 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58479-042-0096 g in 1 CAN; Type 0: Not a Combination Product01/17/2016
    2NDC:58479-042-01170 g in 1 CAN; Type 0: Not a Combination Product01/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/17/2016
    Labeler - Crossing Cultures, LLC dba Goddess Garden (078444606)