TEINT COUTURE EVERWEAR 24H WEAR SATIN FINISH FULL COVERAGE AND COMFORT BROAD SPECTRUM SPF 20 N365- octinoxate, titanium dioxide cream

TEINT COUTURE EVERWEAR 24h Wear Satin Finish Full Coverage and Comfort Broad Spectrum SPF 20 N365 by

Drug Labeling and Warnings

TEINT COUTURE EVERWEAR 24h Wear Satin Finish Full Coverage and Comfort Broad Spectrum SPF 20 N365 by is a Otc medication manufactured, distributed, or labeled by LVMH FRAGRANCE BRANDS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Octinoxate 3.00%

Titanium Dioxide 1.75%

Sunscreen

Use

• 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 Poison Control Center right away.

Other information

• Protect the product in this container from excessive heat and direct sun

Inactive ingredients

water (aqua), methyl trimethicone, isododecane, alcohol, dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone, acrylates/dimethicone copolymer, glycerin, diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane crosspolymer, diisostearyl malate, disteardimonium hectorite, sodium myristoyl glutamate, aluminum hydroxide, glyceryl undecyl dimethicone, phenoxyethanol, propylene carbonate, vp/va copolymer, stearic acid, fragrace (parfum), tetrasodium EDTA, dipotassium glycyrrhizate, geraniol, BHT, citronellol, tocopherol. May contain: titanium dioxide, iron oxides.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-855-424-8563 Monday-Friday 9am to 5pm EST consumerservices@lvmhfb.com

Package Labeling: (

60905-0828-0)

Package Labeling: (

60905-0828-1)

Package Labeling: (

60905-0828-2)

INGREDIENTS AND APPEARANCE

TEINT COUTURE EVERWEAR 24H WEAR SATIN FINISH FULL COVERAGE AND COMFORT BROAD SPECTRUM SPF 20 N365 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60905-0828
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GERANIOL (UNII: L837108USY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60905-0828-0	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/01/2019
2	NDC: 60905-0828-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2019
3	NDC: 60905-0828-2	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2019

Labeler - LVMH FRAGRANCE BRANDS (275474252)