Label: FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF33 CHOCOLATE- octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 61722-211-00 - 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)
- flormar REBORN FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF33 Chocolate 30ml (61722-211-00)
- Active ingredient
- Uses
- Warnings
-
Directions
- Shake well before use.
- Apply drop by drop with fingertips.
- 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
-
Inactive ingredients
water, cyclopentasiloxane, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, propanediol, polysilicone-11, glycerin, SD alcohol 40-B, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, disteardimonium hectorite, trimethylsiloxysilicate, methyl methacrylate crosspolymer, sodium chloride, triethoxycaprylysilane, aluminum hydroxide, sodium PCA, ethylhexylglycerin, fragrance, urea, Anogeissus leiocarpus bark extract, algae extract, soluble collagen, silica, laureth-12, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin, propylene glycol, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linumusitatissium) seed extract, sodium dehydroacetate, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethylionone, linalool, titanium dioxide, iron oxides.
- Product Labels
-
INGREDIENTS AND APPEARANCE
FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF33 CHOCOLATE
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61722-211 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) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) UREA (UNII: 8W8T17847W) ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAURETH-12 (UNII: OAH19558U1) TREHALOSE (UNII: B8WCK70T7I) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COTTON SEED (UNII: DI0ZRJ0MXN) FLAX SEED (UNII: 4110YT348C) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LINALOOL, (+/-)- (UNII: D81QY6I88E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61722-211-00 1 in 1 BOX 07/06/2014 1 30 mL in 1 BOTTLE; 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 07/06/2014 Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
