KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide spray 
Crossing Cultures LLC dba Goddess Garden

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.

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Kids Natural Mineral Sunscreen Broad Spectrum SPF 30 Spray

Drug Facts

Active Ingredients

Titanium Dioxide 6.4%, Zinc Oxide 6.0%

Purpose

Sunscreen

Uses

Warnings

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 to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control 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. • Shake well. Should spray white lotion. Rub in. • Do not spray directly onto 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 80 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 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*, Polygylceryl-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

Package Labeling:

KNATCS

KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM  SPF 30
titanium dioxide, zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-032
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
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LAVANDIN OIL (UNII: 9RES347CKG)  
POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58479-032-0096 g in 1 CAN; Type 0: Not a Combination Product01/17/2016
2NDC:58479-032-01170 g in 1 CAN; Type 0: Not a Combination Product01/17/2016
3NDC:58479-032-02227 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
Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)
Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)

Revised: 10/2016
Document Id: 3eb257fc-d4d6-5cb5-e054-00144ff8d46c
Set id: ca29aefd-9662-4d2e-b9ac-fa4b67f7b463
Version: 3
Effective Time: 20161012
 
Crossing Cultures LLC dba Goddess Garden