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 
IT COSMETICS, LLC

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.

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Drug Facts

Active ingredients

Ensulizole 3%

Octisalate 5%

Titanium dioxide 2.8%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

protect the product in this container from excessive heat and direct sun

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?

Call 800-620-3950

image of a carton

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69259-3488
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE28 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69259-3488-11 in 1 CARTON02/01/2024
132 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69259-3488-21 in 1 CARTON02/01/2024
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:69259-3488-31 in 1 CARTON02/01/2024
34 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/01/2024
Labeler - IT COSMETICS, LLC (962591793)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(69259-3488)

Revised: 7/2023
Document Id: f1954de6-9ad3-4991-bb77-cf4a29ad00c6
Set id: f2990320-b61d-40b8-ba79-18d6b37e7f52
Version: 1
Effective Time: 20230717
 
IT COSMETICS, LLC