TEINT COUTURE EVERWEAR 24H WEAR SATIN FINISH FULL COVERAGE AND COMFORT BROAD SPECTRUM SPF 20 Y215- octinoxate, titanium dioxide

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
LVMH Fragrance Brands
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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.
Authorization status:
OTC monograph final
Authorization number:
60905-0811-0, 60905-0811-1

TEINT COUTURE EVERWEAR 24H WEAR SATIN FINISH FULL COVERAGE AND

COMFORT BROAD SPECTRUM SPF 20 Y215- octinoxate, titanium dioxide cream

LVMH Fragrance Brands

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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TEINT COUTURE EVERWEAR - 24h Wear - Satin Finish Full Coverage & Comfort - Broad

Spectrum SPF 20 Y215

Drug Facts

Active ingredient

Octinoxate 3.00%

Titanium Dioxide 1.75%

Sunscreen

Us es

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.

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. – 2 p.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

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, fragrance (parfum), tetrasodium EDTA, dipotassium

glycyrrhizate, geraniol, BHT, citronellol, tocopherol.

May Contain: titanium dioxide, iron oxides.

Questions or comments?

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

Package Labeling:

TEINT COUTURE EVERWEAR 24H WEAR SATIN FINISH FULL COVERAGE

AND COMFORT BROAD SPECTRUM SPF 20 Y215

octinoxate, titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 9 0 5-0 8 11

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

30 mg in 1 mL

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

17.5 mg in 1 mL

LVMH Fragrance Brands

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

METHYL TRIMETHICO NE (UNII: S73ZQI0 GXM)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PEG-9 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE (UNII: TYP8 1E471F)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

SO DIUM MYRISTO YL GLUTAMATE (UNII: AYU7QD8 9 3W)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

GLYCYRRHIZINATE DIPO TASSIUM (UNII: CA2Y0 FE3FX)

GERANIO L (UNII: L8 3710 8 USY)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

.BETA.-CITRO NELLO L, ( R) - (UNII: P0 1OUT9 6 4K)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 9 0 5-0 8 11-1

1 in 1 CARTON

0 4/0 1/20 19

1

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 0 9 0 5-0 8 11-0

8 .8 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 4/0 1/20 19

Labeler -

LVMH Fragrance Brands (275474252)

Revised: 9/2018

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