KIDS 50 SPF50- titanium dioxide, zinc oxide lotion 
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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Goddess Garden Kids SPF50 Lotion

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

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)

Revised: 4/2018
Document Id: 6a0f2536-6499-1dc7-e053-2a91aa0a57ab
Set id: 6a0f2536-6498-1dc7-e053-2a91aa0a57ab
Version: 1
Effective Time: 20180417
 
Crossing cultures LLC dba Goddess Garden