SUNSTATION ALL-NATURAL SPF 30 SUNSCREEN- titanium dioxide, zinc oxide lotion

Sunstation All-Natural SPF 30 Sunscreen by

Drug Labeling and Warnings

Sunstation All-Natural SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sunstation USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredients

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measure (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 consult physician if

irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

• Apply liberally 15-minutes before sun exposure

Reapply:

• At least every two-hours.
• Immediately after swimming, sweating or towel drying.

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 broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

• Limit time in the sun, especially between 10am and 2pm.
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6-months, consult a physician.

OTHER INGREDIENTS:

Aloe Barbadensis (Aloe Vera Gel) juice, Aqua (Deionixed Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin E), Xanthan Gum

OTHER INFORMATIONS:

• Protect this product from excessive heat and direct sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSTATION ALL-NATURAL SPF 30 SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71272-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCONUT OIL (UNII: Q9L0O73W7L)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MANGO (UNII: I629I3NR86)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71272-811-01	1000 g in 1 CONTAINER; Type 0: Not a Combination Product	02/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/28/2017

Labeler - Sunstation USA, LLC (080497172)