MAKEUP SUN PRIMER- octinoxate, zinc oxide, titanium dioxide cream

MAKEUP SUN PRIMER by

Drug Labeling and Warnings

MAKEUP SUN PRIMER by is a Otc medication manufactured, distributed, or labeled by STW ENTERPRISE INC., Nowcos Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAKEUP SUN PRIMER 
octinoxate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70117-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.47 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.06 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70117-001-02	1 in 1 PACKAGE	12/08/2015
1	NDC: 70117-001-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/08/2015

Labeler - STW ENTERPRISE INC. (051490151)

Registrant - STW ENTERPRISE INC. (051490151)

Establishment
Name	Address	ID/FEI	Business Operations
Nowcos Co., Ltd.		689914984	manufacture(70117-001)