CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 025- octinoxate, titanium dioxide, zinc oxide emulsion

CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 025 by

Drug Labeling and Warnings

CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 025 by is a Otc medication manufactured, distributed, or labeled by Parfums Christian Dior. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.00%

Titanium dioxide 4.15%

Zinc oxide 9.80%

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 decreases this risk, regularly use a sunsreen 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, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, DIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PROPANEDIOL, LAURYL PEG-9 POLYDIMETHYLSILOXETHYL DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TRISILOXANE, PHENYL TRIMETHICONE, GLYCERIN, SODIUM CHLORIDE, DIMETHICONE/PEG-/ CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, PHENOXYETHANOL, STEARIC ACID, XYLITOL, POLYMETHYL METHACRYLATE, PARFUM (FRAGRANCE), CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, SILICA, ZINC GLUCONATE, ADENOSINE, BUTYLPHENYL METHYLPROPIONAL, LIMONENE, SYNTHETIC FLUORPHLOGOPITE, PALMARIA PALMATA EXTRACT, SODIUM BENZOATE, ALPHA-ISOMETHYL IONONE, GERANIOL, BUTYLENE GLYCOL, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, ALCOHOL, HYDROGEN DIMETHICONE, BHT, SAPONINS, TOCOPHEROL, AFRAMOMUM ANGUSTIFOLIUM SEED EXTRACT. [MAY CONTAIN: CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

Package Labeling:

INGREDIENTS AND APPEARANCE

CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 025 
octinoxate, titanium dioxide, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61957-2903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	41.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	98 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
PROPANEDIOL (UNII: 5965N8W85T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
TRISILOXANE (UNII: 9G1ZW13R0G)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XYLITOL (UNII: VCQ006KQ1E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
ADENOSINE (UNII: K72T3FS567)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
DULSE (UNII: 7832HOY4ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
AFRAMOMUM ANGUSTIFOLIUM SEED (UNII: OSF83Q896J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61957-2903-0	2 in 1 CARTON	07/01/2018
1		15 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 61957-2903-1	1 in 1 CARTON	07/01/2018
2		15 g in 1 JAR; 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	07/01/2018

Labeler - Parfums Christian Dior (275252245)