Label: FOUNDATION BALANCED SATIN FINISH SPF15- titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69349-100-30 - Packager: Modern Beauty
- 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 November 23, 2014
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- Drug Facts
- Active Ingredient
- Uses:
- Warnings:
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Directions:
- apply liberally 15 minutes before sun exposure
repply
- after 40 minutes of swimming or sweating
- immediately after twoel drying
- at least every 2 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- children under 6 months of age: Ask a doctor.
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Inactive ingredients
water, cyclomethicone, butylene glycol, trimethylsiloxysilicate, vineyl dimethicone crosspolymer, carbonate, silica, sodium chloride, sorbitan sesquioleate, polymethylmethacrylate, magnesium stearate, lauryl peg/ppg-18/18 methicone, sodium hyaluronate, methylparaben, propylparaben, diazolidinyl urea, iodopropynyl butylcarbamate, fragrance, iron oxides (CI77491, CI77492, CI77499)
Made in China
Dist By: Modern Basic Dist. Ltd. Burnaby BC Canada, Garden Grive CA
Formulated for Professional Application. - Other information:
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INGREDIENTS AND APPEARANCE
FOUNDATION BALANCED SATIN FINISH SPF15
titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69349-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) DIMETHICONE (UNII: 92RU3N3Y1O) CARBONATE ION (UNII: 7UJQ5OPE7D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) MAGNESIUM STEARATE (UNII: 70097M6I30) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69349-100-30 1 in 1 CARTON 1 30 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2014 Labeler - Modern Beauty (009651789) Establishment Name Address ID/FEI Business Operations Guangzhou HuaShi Cosmetics Technology CO., Ltd 421359948 manufacture(69349-100)
