Label: BALANCED SATIN FINISH FOUNDATION SPF 15- titanium dioxide, ethylhexyl methoxycinnamate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71305-100-10 - Packager: Modern Basic Distributors Ltd
- 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 April 7, 2017
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- active ingredients
- purpose
- use:
- warnings:
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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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)