Revlon Colorstay Prep & Protect Primer / Base

Revlon Colorstay Prep & Protect Primer / Base
SPL v2
SPL
SPL Set ID 8eebf23e-7fce-dfc0-e053-2995a90ae322
Route
TOPICAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (9 mg) Octinoxate (7.5 mg) Titanium Dioxide (3.6 mg)
Inactive Ingredients
Glycerin Peg-10 Dimethicone (600 Cst) Cyclomethicone 5 Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Perlite Peg-12 Dimethicone/ppg-20 Crosspolymer Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sodium Lactate Aluminum Oxide Trimethylsiloxysilicate (m/q 0.6-0.8) Hexyl Laurate 1,2-hexanediol Brown Iron Oxide Magnesium Sulfate, Unspecified Watermelon Apple Alpha-tocopherol Acetate Phenoxyethanol Edetic Acid Water Peg-9 Polydimethylsiloxyethyl Dimethicone Dimethicone Polymethylsilsesquioxane (4.5 Microns) Polyglyceryl-4 Isostearate Stearic Acid Caprylyl Glycol Lens Culinaris Fruit Salicylic Acid Pyrrolidone Carboxylic Acid Ethylhexyl Palmitate Butylene Glycol Silica Dimethyl Silylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-01

Description

Titanium Dioxide 3.6% Zinc Oxide 9.0% Octinoxate 7.5%

Purpose

Sunscreen


Medication Information

Indications and Usage

Helps prevent sunbunrs. 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.

Purpose

Sunscreen

Dosage and Administration

Apply liberally 15 minutes before sun exposure.

Description

Titanium Dioxide 3.6% Zinc Oxide 9.0% Octinoxate 7.5%

Section 50565-1

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 swollowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Repply at least every 2 hours.

Use a water resistant sunscreen when swimming or sweating

Active Ingredients

Titanium Dioxide 3.6%

Zinc Oxide 9.0%

Octinoxate 7.5%

Inactive Ingredients

CYCLOPENTASILOXANE; AQUA/WATER/EAU; ZINC OXIDE ; ETHYLHEXYL METHOXYCINNAMATE; TRIMETHYLSILOXYSILICATE; GLYCERIN; TITANIUM DIOXIDE; PEG-10 DIMETHICONE; PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE; DIMETHICONE; POLYMETHYLSILSESQUIOXANE; HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER]; HEXYL LAURATE; POLYGLYCERYL-4 ISOSTEARATE; PERLITE; DIMETHICONE/PEG-10/15 CROSSPOLYMER; PHENOXYETHANOL; XANTHAN GUM; MAGNESIUM SULFATE; STEARIC ACID; CAPRYLYL GLYCOL; 1,2-HEXANEDIOL; ALUMINA; CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT]; LENS ESCULENTA (LENTIL) FRUIT EXTRACT; POLYSILICONE-11; PYRUS MALUS (APPLE) FRUIT EXTRACT; IRON OXIDES (CI 77499); TOCOPHERYL ACETATE; SODIUM LACTATE; SODIUM PCA; TETRASODIUM EDTA; ETHYLHEXYL PALMITATE; BUTYLENE GLYCOL; SALICYLIC ACID; SILICA DIMETHYL SILYLATE

Principal Display Panel

REVLON

Colorstay Prep & Protect Primer / Base

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly us sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun proection measures including:

- limit time in the sun, especially from 10a.m - 2p.m.

- wear long -sleeved shirts, pants, hats and sunglasses.

- children under 6 months: Ask a doctor


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunbunrs. 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.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.

Section 50565-1 (50565-1)

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

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 swollowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Repply at least every 2 hours.

Use a water resistant sunscreen when swimming or sweating

Active Ingredients

Titanium Dioxide 3.6%

Zinc Oxide 9.0%

Octinoxate 7.5%

Inactive Ingredients

CYCLOPENTASILOXANE; AQUA/WATER/EAU; ZINC OXIDE ; ETHYLHEXYL METHOXYCINNAMATE; TRIMETHYLSILOXYSILICATE; GLYCERIN; TITANIUM DIOXIDE; PEG-10 DIMETHICONE; PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE; DIMETHICONE; POLYMETHYLSILSESQUIOXANE; HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER]; HEXYL LAURATE; POLYGLYCERYL-4 ISOSTEARATE; PERLITE; DIMETHICONE/PEG-10/15 CROSSPOLYMER; PHENOXYETHANOL; XANTHAN GUM; MAGNESIUM SULFATE; STEARIC ACID; CAPRYLYL GLYCOL; 1,2-HEXANEDIOL; ALUMINA; CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT]; LENS ESCULENTA (LENTIL) FRUIT EXTRACT; POLYSILICONE-11; PYRUS MALUS (APPLE) FRUIT EXTRACT; IRON OXIDES (CI 77499); TOCOPHERYL ACETATE; SODIUM LACTATE; SODIUM PCA; TETRASODIUM EDTA; ETHYLHEXYL PALMITATE; BUTYLENE GLYCOL; SALICYLIC ACID; SILICA DIMETHYL SILYLATE

Principal Display Panel

REVLON

Colorstay Prep & Protect Primer / Base

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly us sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun proection measures including:

- limit time in the sun, especially from 10a.m - 2p.m.

- wear long -sleeved shirts, pants, hats and sunglasses.

- children under 6 months: Ask a doctor


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Raw Label Data

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