Label: FLORMAR BB WHITE BW03 DARK MEDIUM- octinoxate, octocrylene, avobenzone aerosol
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Contains inactivated NDC Code(s)
NDC Code(s): 61722-292-00 - 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 October 18, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
- Wear alone or under foundation.
- Shake well before use.
- 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 of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 30 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.
- Childrenn under 6 months of age: Ask a doctor.
- Other information
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Inactive ingredients
Water, cyclopentasiloxane, polysilicone-11, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, hydrolyzed vegetable flour, ascorbyl tetraisopalmitate, polymethylsilsesquioxane, sodium chloride, stearic acid, methyl methacrylate crosspolymer, silica, fragrance, ethylhexylglycerin, triethoxycaprylylsilane, aluminum hydroxide, laureth-12, caprylyl glycol, hexyl cinnamal benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone,linalool, may contain: titanium dioxide, iron oxides.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
FLORMAR BB WHITE BW03 DARK MEDIUM
octinoxate, octocrylene, avobenzone aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61722-292 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENOXYETHANOL (UNII: HIE492ZZ3T) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) SODIUM CHLORIDE (UNII: 451W47IQ8X) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) LAURETH-12 (UNII: OAH19558U1) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61722-292-00 1 in 1 BOX 05/02/2016 1 40 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 05/02/2016 Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
