Label: MAKEUP SUN PRIMER- octinoxate, zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70117-001-01, 70117-001-02 - Packager: STW ENTERPRISE INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 8, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
MAKEUP SUN PRIMER
octinoxate, zinc oxide, titanium dioxide creamProduct 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)
