Label: FOUNDATION BALANCED SATIN FINISH SPF 15- titanium dioxide, ethylhexyl methoxycinnamate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69349-103-34 - Packager: Modern Beauty Limited
- Category: HUMAN OTC DRUG LABEL
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 6, 2015
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- Active Ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Use
- Warnings
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Directions
•apply liberally 15 minutes before sun exposure
•reapply:
•after 40 minutes of swimming or sweating
•immediately after towel drying
•atleast 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, regulary 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. -
Inactive Ingredients
Water, cyclomethicone, butylene glycol, cyclopentasiloxane, peg-10 dimethicone, trimethylsiloxysilicate, dimethicone/vinyl dimethicone crosspolymer, disteardimonium hectorite, silica, sodium chloride, sorbitan sesquioleate, polymethylmethacrylate, tribehenin, phenoxyethanol, xanthan gum, diazolidinyl urea, iodopropynyl butylcarbamate, sodium hyaluronate (CI 77489, 77491, 77492, 77499).
- Other Information
- Questions
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
FOUNDATION BALANCED SATIN FINISH SPF 15
titanium dioxide, ethylhexyl methoxycinnamate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69349-103 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) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) TRIBEHENIN (UNII: 8OC9U7TQZ0) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) HYALURONATE SODIUM (UNII: YSE9PPT4TH) FERROUS OXIDE (UNII: G7036X8B5H) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69349-103-34 1 in 1 CARTON 11/01/2014 1 40 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 11/01/2014 Labeler - Modern Beauty Limited (009651789) Establishment Name Address ID/FEI Business Operations Guangzhou HuaShi Cosmetics Technology CO., Ltd 421359948 manufacture(69349-103)
