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

Goddess Garden Organics Kids Natural Sunscreen by

Drug Labeling and Warnings

Goddess Garden Organics Kids Natural Sunscreen 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 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

INGREDIENTS AND APPEARANCE

GODDESS GARDEN ORGANICS KIDS NATURAL SUNSCREEN  SPF 30
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58479-043
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58479-043-00	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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58479-042
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58479-042-00	96 g in 1 CAN; Type 0: Not a Combination Product	01/17/2016
2	NDC: 58479-042-01	170 g in 1 CAN; 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)