Label: DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN- octisalate and octocrylene lotion
- NDC Code(s): 49967-906-01
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen 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 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, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides
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INGREDIENTS AND APPEARANCE
DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN
octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-906 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 32 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) METHYLPARABEN (UNII: A2I8C7HI9T) ALCOHOL (UNII: 3K9958V90M) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ISOBUTANE (UNII: BXR49TP611) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM CITRATE (UNII: 1Q73Q2JULR) TOCOPHEROL (UNII: R0ZB2556P8) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-906-01 1 in 1 CARTON 01/01/2017 1 100 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 Drug M020 01/01/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmax USA, Inc. 010990210 manufacture(49967-906)
