MAKEUP SUN PRIMER- octinoxate, zinc oxide, titanium dioxide cream 
STW ENTERPRISE INC.

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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Drug Facts

Ethylhexyl Methoxycinnamate 7.00%
Titanium Dioxide 4.11%
Zinc Oxide 4.93%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Silica, Triethylhexanoin, Phenethyl Benzoate, Butyrospermum Parkii (Shea) Butter, Bis-Ethylhexyloxyphenol MethoxyphenylTriazine, Dimethicone/Vinyl Dimethicone Crosspolymer, Ceresin, Cholesteryl Isostearate, Trimethylsiloxysilicate, PEG-10 Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Citrus Grandis (Grapefruit) Peel Oil, Ocimum Basilicum (Basil) Oil, Geranium Maculatum Oil, Propylene Glycol, Hydroxypropyl Bisstearamide MEA, Macadamia Integrifolia Seed Oil, Butylene Glycol, Argania Spinosa Kernel Oil, Dipropylene Glycol, Behenyl Alcohol, Ceteareth-20, Cholesterol, Cetearyl Alcohol, Squalane, Tricaprin

image description

MAKEUP SUN PRIMER 
octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70117-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.47 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.06 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
SHEA BUTTER (UNII: K49155WL9Y)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
CERESIN (UNII: Q1LS2UJO3A)  
CHOLESTERYL ISOSTEARATE (UNII: JD5KDN9464)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
BASIL OIL (UNII: Z129UMU8LE)  
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROXYPROPYL BISSTEARAMIDE MONOETHANOLAMIDE (UNII: EQ4H84545F)  
MACADAMIA OIL (UNII: 515610SU8C)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ARGAN OIL (UNII: 4V59G5UW9X)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DOCOSANOL (UNII: 9G1OE216XY)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SQUALANE (UNII: GW89575KF9)  
TRICAPRIN (UNII: O1PB8EU98M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70117-001-021 in 1 PACKAGE12/08/2015
1NDC:70117-001-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/08/2015
Labeler - STW ENTERPRISE INC. (051490151)
Registrant - STW ENTERPRISE INC. (051490151)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos Co., Ltd.689914984manufacture(70117-001)

Revised: 12/2015
Document Id: a9df4a5e-3c87-4a4d-9af7-2561324bd4ff
Set id: 1be9d02e-64c1-4a62-9549-e0819c9d811f
Version: 2
Effective Time: 20151208
 
STW ENTERPRISE INC.