KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide spray

Kids Natural Mineral Sunscreen Broad Spectrum by

Drug Labeling and Warnings

Kids Natural Mineral Sunscreen Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by Crossing Cultures LLC dba Goddess Garden. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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:

INGREDIENTS AND APPEARANCE

KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM  SPF 30
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58479-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58479-032-00	96 g in 1 CAN; Type 0: Not a Combination Product	01/17/2016
2	NDC: 58479-032-01	170 g in 1 CAN; Type 0: Not a Combination Product	01/17/2016
3	NDC: 58479-032-02	227 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/17/2016

Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)

Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)