NDC | 69349-103-34 |
Set ID | f748957e-7ec1-43f4-b9f6-1c45b5ebb126 |
Category | HUMAN OTC DRUG LABEL |
Packager | Modern Beauty Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Use
- Warnings
-
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
-
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)