Capture Dreamskin Fresh & Perfect Cushion With Sunscreen Broad Spectrum Spf 50 010

Capture Dreamskin Fresh & Perfect Cushion With Sunscreen Broad Spectrum Spf 50 010
SPL v2
SPL
SPL Set ID 775f4009-9fc2-475b-a141-b4b5e5542180
Route
TOPICAL
Published
Effective Date 2020-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.07 mg) Titanium Dioxide (0.0415 mg) Zinc Cation (0.098 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-26

Description

Octinoxate 7.00% Titanium dioxide 4.15% Zinc oxide 9.80%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Octinoxate 7.00% Titanium dioxide 4.15% Zinc oxide 9.80%

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the Sun. see Directions
Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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.

. 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 Sun Protection Measures

including:

Do Not Use

on damaged or broken skin.

Drug Facts

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients

Octinoxate 7.00%

Titanium dioxide 4.15%

Zinc oxide 9.80%

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)

When Using This Product,

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor 

if rash occurs.

Package Labeling(refill 15g)

Package Labeling(tester 15g)

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Contral Center right away.


Structured Label Content

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the Sun. see Directions
Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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.

. 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 Sun Protection Measures

including:

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients

Octinoxate 7.00%

Titanium dioxide 4.15%

Zinc oxide 9.80%

Inactive Ingredients: (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)

When Using This Product, (When using this product,)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor  (Stop use and ask a doctor )

if rash occurs.

Package Labeling(refill 15g) (Package Labeling(REFILL 15g))

Package Labeling(tester 15g) (Package Labeling(TESTER 15g))

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Contral Center right away.


Advanced Ingredient Data


Raw Label Data

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