Label: FLORMAR LIP MOISTURIZER STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 15- octinoxate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 61722-254-00 - 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
- Use
- Warnings
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Directions
- Apply on the lips. Reapply when lips are exposed to strong sun for protection.
- 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
DIISOSTEARYL MALATE, TRIDECYL TRIMELLITATE, OCTYLDODECANOL, HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, POLYETHYLENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, TRIISOSTEARYL CITRATE, SILICA, MICROCRYSTALLINE WAX, MICA, CANDELILLA (EUPHORBIA CERIFERA) WAX, ZINC OXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYMETHYL METHACRYLATE, PENTAERTHRITYL TETRABEHENATE, POLYBUTENE, SHEA (BUTYROSPERMUM PARKII) BUTTER, COCOA (THEOBROMA COCAO) SEED BUTTER, CASTOR (RICINUS COMMUNIS) SEED OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, FLAVOR, PEG-8, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANDIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, TITANIUM DIOXIDE, D&C RED NO. 28 ALUMINUM LAKE, D&C RED NO. 6., FD&C YELLOW NO.5 ALUMINUM LAKE.
- Product Label
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INGREDIENTS AND APPEARANCE
FLORMAR LIP MOISTURIZER STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 15
octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61722-254 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 68 mg in 1 g Inactive Ingredients Ingredient Name Strength DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) OCTYLDECANOL (UNII: 07UG7TSU58) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIISOSTEARYL CITRATE (UNII: 50XT325OOH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) ZINC OXIDE (UNII: SOI2LOH54Z) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LAUROYL LYSINE (UNII: 113171Q70B) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBYL PALMITATE (UNII: QN83US2B0N) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61722-254-00 1 in 1 BOX 01/30/2015 1 3 g 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 01/30/2015 Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
