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

• 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 the sun, especially from 10am to 2pm. • 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.

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, Steric Acid, Tocopherol (Vitamin E), Xanthan Gum *Certified Organic

Questions or Comments

Toll-free 1-855-SAFE-SUN or

www.GoddessGarden.com

Package Labeling:

Label5

EVERYDAY NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58479-036
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SAFFLOWER OIL (UNII: 65UEH262IS)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAVANDIN OIL (UNII: 9RES347CKG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58479-036-00	28 g in 1 TUBE; Type 0: Not a Combination Product	01/16/2016
2	NDC:58479-036-01	96 g in 1 TUBE; Type 0: Not a Combination Product	01/16/2016
3	NDC:58479-036-02	170 g in 1 TUBE; Type 0: Not a Combination Product	01/16/2016
4	NDC:58479-036-03	6 g in 1 PACKET; Type 0: Not a Combination Product	01/16/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/16/2016

Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)

Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)

Everyday Natural Mineral Sunscreen Broad Spectrum SPF 30 Lotion