Label: IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NATURAL MATTE COLOR CORRECTING PORE REFINING FULL COVERAGE SKIN BALANCING SERUM BROAD SPECTRUM SPF 40 SUNSCREEN- ensulizole, octisalate and titanium dioxide cream
- NDC Code(s): 69259-3488-1, 69259-3488-2, 69259-3488-3
- Packager: IT COSMETICS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 17, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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.
-
Directions
● shake well before 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
-
Inactive ingredients
water, dimethicone, isododecane, butylene glycol, silica, cetyl PEG/PPG-10/1 dimethicone, glycerin, isohexadecane, niacinamide, trimethylsiloxysilicate, synthetic fluorphlogopite, butyloctyl salicylate, dimethicone crosspolymer, sodium chloride, aluminum starch octenylsuccinate, phenoxyethanol, silica silylate, disodium stearoyl glutamate, sorbitan isostearate, polyglyceryl-4 isostearate, sodium hydroxide, aluminum hydroxide, hexyl laurate, stearic acid, chlorphenesin, caprylyl glycol, lens esculenta (lentil) seed extract, trisodium ethylenediamine disuccinate, sodium hyaluronate, tocopherol, adenosine, kaolin, ethylhexylglycerin, steareth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, potassium sorbate, palmitoyl tripeptide-1, chrysin, palmitoyl tetrapeptide-7, citric acid, biotin; may contain titanium dioxide, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NATURAL MATTE COLOR CORRECTING PORE REFINING FULL COVERAGE SKIN BALANCING SERUM BROAD SPECTRUM SPF 40 SUNSCREEN
ensulizole, octisalate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69259-3488 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 28 mg in 1 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) NIACINAMIDE (UNII: 25X51I8RD4) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYL LAURATE (UNII: 4CG9F9W01Q) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LENTIL (UNII: 6O38V6B52O) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) ADENOSINE (UNII: K72T3FS567) KAOLIN (UNII: 24H4NWX5CO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARETH-20 (UNII: L0Q8IK9E08) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T) SODIUM CITRATE (UNII: 1Q73Q2JULR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) CHRYSIN (UNII: 3CN01F5ZJ5) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BIOTIN (UNII: 6SO6U10H04) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69259-3488-1 1 in 1 CARTON 02/01/2024 1 32 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69259-3488-2 1 in 1 CARTON 02/01/2024 2 12 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69259-3488-3 1 in 1 CARTON 02/01/2024 3 4 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 final M020 02/01/2024 Labeler - IT COSMETICS, LLC (962591793) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp. 783200723 manufacture(69259-3488)
