CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010: Package Insert and Label Information

CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010- octinoxate, titanium dioxide and zinc oxide emulsion
Parfums Christian Dior

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.

Drug Facts

Active Ingredients

Octinoxate 7.00%

Titanium dioxide 4.15%

Zinc oxide 9.80%

Purpose

Antiseptic

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 Contral 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 docto.

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 •LAURYLPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE• HDVTRIMETHYLOL HEXYLLACTONE
CROSSPOLYMER TRISILOXANE •PHENYL TRIMETHICONE• POLYMETHYL METHACRYLATE•GLYCERIN •SODIUM CHLORIDE• DIMETHICONE/PEG-10/15 CROSSPOLYMER •ALUMINUM HYDROXDE• DISTEARDIMONIUM HECTORITE •PHENOXYETHANOL •STEARIC ACID•
XYLITOL •TRIETHOXYCAPRYLYLSILANE• PARFUM (FRAGRANCE) •CAPRYLYL GLYCOL•ETHYLHEXYLGLYCERIN •DISODIUM EDTA •SILICA •ZINC GLUCONATE• ADENOSINE•SYNTHETNC FLUORPHLOGOPITE •PALMARIA PALMAIA EXTRACT•LIMONENE•SODIUMBENZOATE•GERANIOL •ALPHA-ISOMETHYL IONONE• BUTYLENE GLYCOL• JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT• CITRONELLOL• ALCOHOL• TOCOPHEROL•
HYDROGEN DIMETHICONE•SAPONINS• AFRAMOMUM ANGUSTIFOLIUM SEED EXTRACT.[MAY CONTAIN: CI 77491, CI77492, CI 77499 (IRON OXIDES) •CI 77891 (TITANIUM DIOXIDE)].

Package Labeling(2*15g)

bottle
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Package Labeling(TESTER 15g)

bottle4
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Package Labeling(REFILL 15g)

bottle 2
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CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010
octinoxate,titanium dioxide,zinc oxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61957-2300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.07 mg in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.0415 mg in 1 g
ZINC OXIDE (ZINC CATION) ZINC CATION 0.098 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PEG-10 DIMETHICONE (600 CST)
DIMETHICONE
BUTYLENE GLYCOL
PROPANEDIOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
TRISILOXANE
PHENYL TRIMETHICONE
POLY(METHYL METHACRYLATE; 450000 MW)
GLYCERIN
SODIUM CHLORIDE
DIMETHICONE/PEG-10/15 CROSSPOLYMER
ALUMINUM HYDROXIDE
DISTEARDIMONIUM HECTORITE
PHENOXYETHANOL
STEARIC ACID
XYLITOL
TRIETHOXYCAPRYLYLSILANE
CAPRYLYL GLYCOL
ETHYLHEXYLGLYCERIN
EDETATE DISODIUM ANHYDROUS
SILICON DIOXIDE
ADENOSINE
PALMARIA PALMATA
LIMONENE, (+)-
SODIUM BENZOATE
GERANIOL
ISOMETHYL-.ALPHA.-IONONE
JASMINUM OFFICINALE FLOWER
.BETA.-CITRONELLOL, (R)-
ALCOHOL
TOCOPHEROL
AFRAMOMUM ANGUSTIFOLIUM SEED
FERRIC OXIDE RED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61957-2300-0 2 JAR in 1 PACKAGE contains a JAR
1 15 g in 1 JAR This package is contained within the PACKAGE (61957-2300-0)
2 NDC:61957-2300-1 15 g in 1 JAR None
3 NDC:61957-2300-2 15 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/26/2020
Labeler — Parfums Christian Dior (275252245)

Revised: 11/2020 Parfums Christian Dior

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