Label: FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP24 MEDIUM- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61722-168-00 - 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
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- Official Label (Printer Friendly)
- flormar REBORN BB CREAM SUNSCREEN BROAD SPECTRUM SPF 30 CP24 Medium
- Active ingredient
- Uses
- Warnings
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Directions
- Apply to face with a make-up sponge.
- 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:
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- 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
neopentyl glycol diethylhexanoate, ethylhexyl palmitate, polyethylene, hydrogenated polyisobutene, isononyl isononanoate, octyldodecyl stearoyl stearate, aluminum starch octenyl succinate, candelilla (Candelilla cera) wax, pentaerythrityl tetrabehenate, isocetyl stearoyl stearate, jojoba (Simmondsia chinensis) seed oil, squalane, nylon-12, polyglyceryl-3 diisostearate, cyclopentasiloxane, polymethylsilsesquioxane, dimethicone/vinyl dimethicone crosspolymer, triethoxycaprylylsilane, aluminum hydroxide, fragrance, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, silica, stearic acid, PEG-8, tocopherol, ascorbyl palmitate, ascorbic acid, citric acid, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides
- Product Labels
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INGREDIENTS AND APPEARANCE
FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP24 MEDIUM
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61722-168 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) ETHYLHEXYL PALMITATE (UNII: 2865993309) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CANDELILLA WAX (UNII: WL0328HX19) PENTAERYTHRITYL TETRABEHENATE (UNII: 9MNZ044IRY) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) JOJOBA OIL (UNII: 724GKU717M) SQUALANE (UNII: GW89575KF9) NYLON-12 (UNII: 446U8J075B) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBYL PALMITATE (UNII: QN83US2B0N) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LINALOOL, (+/-)- (UNII: D81QY6I88E) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) BENZYL SALICYLATE (UNII: WAO5MNK9TU) GERANIOL (UNII: L837108USY) COUMARIN (UNII: A4VZ22K1WT) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61722-168-00 1 in 1 BOX 07/06/2014 1 12 g in 1 CONTAINER; 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)
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