Label: PRETTY BY FLORMAR WEIGTHLESS FOUNDATION 007 NEUTRAL- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61722-339-00 - 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 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 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 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, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, glycerin, panthenol, sodium chloride, triethoxycaprylylsilane, polysilicone-11, aluminum hydroxide, fragrance, ethylhexylglycerin, fig (ficus carica) fruit extract, cotton (gossypium hirsutum) seed extract, linseed (linum usitatissimum) seed extract, may contain: titanium dioxide, iron oxides.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PRETTY BY FLORMAR WEIGTHLESS FOUNDATION 007 NEUTRAL
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61722-339 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) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) COTTON SEED (UNII: DI0ZRJ0MXN) FLAX SEED (UNII: 4110YT348C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61722-339-00 1 in 1 BOX 06/20/2017 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 06/20/2017 Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
