DIOR PRESTIGE LE NECTAR DE TEINT EXCEPTIONAL REVITALIZING FOUNDATION SATIN RADIANCE WITH SUNSCREEN BROAD SPECTRUM SPF20 TINTS 020- octinoxate, titanium dioxide emulsion

DIOR PRESTIGE LE NECTAR DE TEINT Exceptional Revitalizing Foundation Satin Radiance with Sunscreen Broad Spectrum SPF20 TINTS 020 by

Drug Labeling and Warnings

DIOR PRESTIGE LE NECTAR DE TEINT Exceptional Revitalizing Foundation Satin Radiance with Sunscreen Broad Spectrum SPF20 TINTS 020 by is a Otc medication manufactured, distributed, or labeled by Parfums Christian Dior. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 3.00 %

Titanium Dioxide 2.92 %

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

• 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

AQUA (WATER), CYCLOPENTASILOXANE, ISODODECANE, ISONONYL ISONONANOATE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, MICA, GLYCERIN, PHENYL TRIMETHICONE, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL, SORBITAN SESQUIOLEATE, POLYSILICONE-11, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, DIMETHICONE, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, SODIUM MYRISTOYL GLUTAMATE, STEARIC ACID, GLYCERYL UNDECYL DIMETHICONE, PARFUM (FRAGRANCE), SODIUM CHLORIDE, TETRASODIUM EDTA, TOCOPHERYL ACETATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PROPYLENE CARBONATE, CELLULOSE, BHT, CITRIC ACID, ROSE EXTRACT, CENTELLA ASIATICA LEAF EXTRACT, SODIUM BENZOATE, POTASSIUM SORBATE, ROSA HYBRID CALLUS CULTURE EXTRACT, MALVA SYLVESTRIS (MALLOW) EXTRACT, ROSA DAMASCENA FLOWER WATER, TOCOPHEROL.
[MAY CONTAIN: CI 77163 (BISMUTH OXYCHLORIDE), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

Package Labeling:

INGREDIENTS AND APPEARANCE

DIOR PRESTIGE LE NECTAR DE TEINT EXCEPTIONAL REVITALIZING FOUNDATION SATIN RADIANCE WITH SUNSCREEN BROAD SPECTRUM SPF20 TINTS 020 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61957-2225
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	29.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISODIUM MYRISTOYL GLUTAMATE (UNII: 3LVY1001N6)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61957-2225-1	1 in 1 CARTON	07/23/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/23/2016

Labeler - Parfums Christian Dior (275252245)