Label: FLORMAR SMOOTH TOUCH FOUNDATION 07 GOLDEN NEUTRAL- octinoxate aerosol
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Contains inactivated NDC Code(s)
NDC Code(s): 61722-276-00 - Packager: Kosan Kozmetik Sanayi ve Ticaret A.S.
- 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 January 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
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Directions
- Shake well before use.
- After use, close the cap properly.
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Sun Protection Measures. Spending time in the sun increases your risk if 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.
- Other information
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Inactive ingredients
water, dimethicone, cyclopentasiloxane, butylene glycol, PEG-10 dimethicone, polymethylsilsesquioxane, glycerin, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, sodium chloride, polysilicone-11, triethoxycaprylylsilane, aluminum hydroxide, sodium PCA, fragrance, urea, caprylic/capric triglyceride, ethylhexylglycerin, algae extract, soluble collagen, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, cymbidium grandiflorum flower extract, nelumbo nucifera flower extract, sodium hyaluronate, chlorphenesin, propylene glycol, fig (ficus carica) fruit extract, cotton (gossypium hirsutum) seed extract, linseed (linum usitatissimum seed extract, sodium dehydroacetate. may contain: titanium dioxide, iron oxides.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
FLORMAR SMOOTH TOUCH FOUNDATION 07 GOLDEN NEUTRAL
octinoxate aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61722-276 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) UREA (UNII: 8W8T17847W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TREHALOSE (UNII: B8WCK70T7I) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) CYMBIDIUM HOOKERIANUM FLOWER (UNII: H2DJ03DI5I) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FIG (UNII: TGD87RII2U) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61722-276-00 1 in 1 BOX 02/11/2016 1 30 mL in 1 TUBE; 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 02/11/2016 Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)