SPL v1
SPL
SPL Set ID 60ed4d6c-a648-47df-86c2-ad4a755bbd08
Route
TOPICAL
Published
Effective Date 2017-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.60 g) Zinc Cation (0.26 g)
Inactive Ingredients
Water Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-01

Description

Active ingredients: TITANIUM DIOXIDE 11.45%, ZINC OXIDE 1.91%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

- Helps to cover blemishes

- Helps for clear and healthier complexion

- Provides sun protection

Directions:

Apply a proper amount on face using the enclosed puff.

Warnings

Warnings: For external use only Avoid contact with eyes. Rinse with water to remove. Discontinue use and consult a doctor if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center immediately.

Active Ingredient

Active ingredients: TITANIUM DIOXIDE 11.45%, ZINC OXIDE 1.91%

Inactive Ingredient

Inactive ingredients: Water, Caprylyl Methicone, Butyloctyl Salicylate, Isotridecyl Isononanoate, Methylpropanediol, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Bis-Hydroxyethoxypropyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Iron Oxides(CI 77492), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Magnesium Sulfate, Iron Oxides(CI 77491), Glycerin, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylyl Glycol, Aluminum Hydroxide, Stearic Acid, Iron Oxides(CI 77499), Portulaca Oleracea Extract, Silica Dimethyl Silylate, Ethylhexylglycerin, Methicone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Pelargonium Graveolens Flower Oil, Butylene Glycol, 1,2-Hexanediol, Salvia Officinalis (Sage) Oil, Pogostemon Cablin Oil, Tocopherol, Hyaluronic Acid, Camellia Japonica Flower Extract, Prunus Serrulata Flower Extract, Acer Saccharum (Sugar Maple) Extract, Rose Extract, Soluble Collagen, Arginine, Ceramide Np, Elastin

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only Avoid contact with eyes. Rinse with water to remove. Discontinue use and consult a doctor if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center immediately.

Description (DESCRIPTION)

Uses:

- Helps to cover blemishes

- Helps for clear and healthier complexion

- Provides sun protection

Directions:

Apply a proper amount on face using the enclosed puff.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: TITANIUM DIOXIDE 11.45%, ZINC OXIDE 1.91%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Caprylyl Methicone, Butyloctyl Salicylate, Isotridecyl Isononanoate, Methylpropanediol, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Bis-Hydroxyethoxypropyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Iron Oxides(CI 77492), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Magnesium Sulfate, Iron Oxides(CI 77491), Glycerin, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylyl Glycol, Aluminum Hydroxide, Stearic Acid, Iron Oxides(CI 77499), Portulaca Oleracea Extract, Silica Dimethyl Silylate, Ethylhexylglycerin, Methicone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Pelargonium Graveolens Flower Oil, Butylene Glycol, 1,2-Hexanediol, Salvia Officinalis (Sage) Oil, Pogostemon Cablin Oil, Tocopherol, Hyaluronic Acid, Camellia Japonica Flower Extract, Prunus Serrulata Flower Extract, Acer Saccharum (Sugar Maple) Extract, Rose Extract, Soluble Collagen, Arginine, Ceramide Np, Elastin

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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