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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunstation All-Natural SPF-30 Sunscreen

Drug Facts:

Uses:

Warnings

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:

Reapply:

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:

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.

OTHER INFORMATIONS:

Package Labeling:

Label

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)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARROT (UNII: L56Z1JK48B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SESAME OIL (UNII: QX10HYY4QV)  
COCOA (UNII: D9108TZ9KG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
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)

Revised: 2/2017
Document Id: 499d366a-a7f5-6070-e054-00144ff88e88
Set id: 499d366a-a7f1-6070-e054-00144ff88e88
Version: 1
Effective Time: 20170228
 
Sunstation USA, LLC