TEINT COUTURE CITY BALM - RADIANT PERFECTING SKIN TINT 24H WEAR MOISTURIZER URBAN SHIELD SPECTRUM SPF 25 N200- octinoxate, titanium dioxide cream

TEINT COUTURE CITY BALM - Radiant Perfecting Skin Tint 24h Wear Moisturizer Urban Shield SPECTRUM SPF 25 by

Drug Labeling and Warnings

TEINT COUTURE CITY BALM - Radiant Perfecting Skin Tint 24h Wear Moisturizer Urban Shield SPECTRUM SPF 25 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.

Directions

• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2p.m.
• wear long-sleeve 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

aqua (water), methyl trimethicone, alcohol, isododecane, phenyl trimethicone, butylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, glycerin, acrylates/dimethicone copolymer, vinyl dimethicone/methicone silsesquioxane crosspolymer, disteardimonium hectorite, sodium myristoyl glutamate, glyceryl undecyl dimethicone, phenoxyethanol, aluminum hydroxide, xanthan gum, propylene carbonate, dimethicone, VP/VA copolymer, stearic acid, sodium hyaluronate, tetrasodium EDTA, parfum (fragrance), dipotassium glycyrrhizate, butyrospermum parkii (shea) seedcake extract, BHT, geraniol, May contain : titanium dioxide, iron oxides.

Package Labeling: 60905-0835-0

Package Labeling: 60905-0835-1

Package Labeling: 60905-0835-2

INGREDIENTS AND APPEARANCE

TEINT COUTURE CITY BALM - RADIANT PERFECTING SKIN TINT 24H WEAR MOISTURIZER URBAN SHIELD SPECTRUM SPF 25  N200
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60905-0835
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)
ALCOHOL (UNII: 3K9958V90M)
ISODODECANE (UNII: A8289P68Y2)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
GLYCERIN (UNII: PDC6A3C0OX)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIMETHICONE (UNII: 92RU3N3Y1O)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60905-0835-0	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2019
2	NDC: 60905-0835-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2019
3	NDC: 60905-0835-2	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2019

Labeler - LVMH Fragrance Brands (275474252)

Establishment
Name	Address	ID/FEI	Business Operations
LVMH Fragrance Brands		394954143	manufacture(60905-0835)