NDC | 71305-100-10 |
Set ID | 63bd03ad-0aab-445d-a1e6-548eb3d52ebf |
Category | HUMAN OTC DRUG LABEL |
Packager | Modern Basic Distributors Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- active ingredients
- purpose
- use:
- warnings:
- KEEP OUT OF REACH OF CHILDREN
-
directions:
•apply liberally 15 minutes before sun exposure
•reapply after 40 minutes of swimming or sweating
•reapply immediately after towel drying
•reapply 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 am to 2 pm
•wear long-sleeved shirts, pants, hats, and sunglasses
•children under 6 months of age: ask a doctor
-
inactive ingredients
water, cyclopentasiloxane, butylene glycol, trimethylsiloxysilicate, PEG-10 dimethicone, silica, methicone, polymethyl methacrylate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lauryl PEG/PPG-18/18 methicone, sorbitan sesquioleate, disteardimonium hectorite, propylene carbonate, tribehenin, xanthan gum, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, sodium hyaluronate, magnesium stearate, sodium chloride, phenoxyethanol, ethylhexylglycerin, methylisothiazolinone, parfum, CI 77489, CI 77491, CI77492, CI 77499.
- other information:
- questions:
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
BALANCED SATIN FINISH FOUNDATION SPF 15
titanium dioxide, ethylhexyl methoxycinnamate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71305-100 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 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHICONE (20 CST) (UNII: 6777U11MKT) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PROPYLENE CARBONATE (UNII: 8D08K3S51E) TRIBEHENIN (UNII: 8OC9U7TQZ0) XANTHAN GUM (UNII: TTV12P4NEE) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYALURONATE SODIUM (UNII: YSE9PPT4TH) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 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:71305-100-10 1 in 1 BOX 03/01/2017 1 40 mL in 1 BOTTLE, GLASS; 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 03/01/2017 Labeler - Modern Basic Distributors Ltd (208909999)