IT COSMETICS YOUR SKIN BUT BETTER CC PLUS COLOR CORRECTING FULL COVERAGE ANTIAGING HYDRATING SERUM BROAD SPECTRUM SPF 50 PLUS CLEAR SUNSCREEN- homosalate, octisalate and octocrylene cream

IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear Sunscreen by

Drug Labeling and Warnings

IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear Sunscreen by is a Otc medication manufactured, distributed, or labeled by IT COSMETICS, LLC, Englewood Lab, Inc., L'OREAL USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 4%

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

Flammable until dry.

Do not use near fire, flame, or heat.

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

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

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

Inactive ingredients

water, dimethicone, propanediol, alcohol denat., synthetic fluorphlogopite, niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, caffeine, tocopherol, PEG-30 dipolyhydroxystearate, disodium stearoyl glutamate, disteardimonium hectorite, polyglyceryl-4 iisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, scutellaria baicalensis root extract, aluminum hydroxide, butylene glycol, adenosine, sodium hyaluronate, snail secretion filtrate, glycerin, ethyl hexanediol, steareth-20, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, potassium sorbate, palmitoyl tripeptide-1, chrysin, palmitoyl tetrapeptide-7, citric acid, biotin; may contain: iron oxides, titanium dioxide

Questions?

Call 800-620-3956

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS YOUR SKIN BUT BETTER CC PLUS COLOR CORRECTING FULL COVERAGE ANTIAGING HYDRATING SERUM BROAD SPECTRUM SPF 50 PLUS CLEAR SUNSCREEN 
homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69259-5908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPANEDIOL (UNII: 5965N8W85T)
ALCOHOL (UNII: 3K9958V90M)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
NIACINAMIDE (UNII: 25X51I8RD4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
CAFFEINE (UNII: 3G6A5W338E)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
ETHOHEXADIOL (UNII: M9JGK7U88V)
STEARETH-20 (UNII: L0Q8IK9E08)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69259-5908-1	1 in 1 CARTON	11/01/2022
1		32 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69259-5908-2	1 in 1 CARTON	11/01/2022
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69259-5908-3	1 in 1 CARTON	11/01/2022
3		4 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 69259-5908-4	1 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/01/2022

Labeler - IT COSMETICS, LLC (962591793)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		172198223	pack(69259-5908)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA Products, Inc.		624244349	manufacture(69259-5908)

Establishment
Name	Address	ID/FEI	Business Operations
Paklab		177711082	manufacture(69259-5908)