KIDS 50 SPF50- titanium dioxide, zinc oxide lotion

Kids 50 by

Drug Labeling and Warnings

Kids 50 by is a Otc medication manufactured, distributed, or labeled by Crossing cultures LLC dba Goddess Garden, Crossing Cultures LLC dba Goddess Garden. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

KIDS 50  SPF50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58479-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58479-206-02	100 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2016

Labeler - Crossing cultures LLC dba Goddess Garden (078444606)

Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)