SPL v1
SPL
SPL Set ID c2875f0c-9f8e-4423-bc3e-724c87458e3c
Route
TOPICAL
Published
Effective Date 2016-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.37 g)
Inactive Ingredients
Talc Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-08-20

Description

Active Ingredient: Titanium Dioxide 7.4%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

INSTRUCTIONS: Achieve a beautiful flush on your skin with this pigmented blush.

Directions: With a brush, dab on the center of both cheeks then follow with spreading out by dabbing around the face line

Caution

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

Active Ingredient

Active Ingredient: Titanium Dioxide 7.4%

Inactive Ingredient

Inactive Ingredients: Talc, Mica (CI 77019), Yellow 6 Lake (CI 15985), Octyldodecyl Stearoyl Stearate, Phenyl Trimethicone, Nylon-12, Silica, Magnesium Myristate, Yellow 5 Lake (CI 19140), Propanediol, Dimethiconol Stearate, Magnesium Stearate, Dimethicone, Red 30 (CI 73360), Ethylhexyl Methoxycinnamate, Caprylic/Capric Triglyceride, Red 36 (CI 12085), Methicone, Sodium Dehydroacetate, Tocopheryl Acetate, Iron Oxides (CI 77491), Tin Oxide (CI 77861), Iron Oxides (CI 77499)

Package Label.principal Display Panel


Structured Label Content

Caution (CAUTION)

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

INSTRUCTIONS: Achieve a beautiful flush on your skin with this pigmented blush.

Directions: With a brush, dab on the center of both cheeks then follow with spreading out by dabbing around the face line

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 7.4%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Talc, Mica (CI 77019), Yellow 6 Lake (CI 15985), Octyldodecyl Stearoyl Stearate, Phenyl Trimethicone, Nylon-12, Silica, Magnesium Myristate, Yellow 5 Lake (CI 19140), Propanediol, Dimethiconol Stearate, Magnesium Stearate, Dimethicone, Red 30 (CI 73360), Ethylhexyl Methoxycinnamate, Caprylic/Capric Triglyceride, Red 36 (CI 12085), Methicone, Sodium Dehydroacetate, Tocopheryl Acetate, Iron Oxides (CI 77491), Tin Oxide (CI 77861), Iron Oxides (CI 77499)

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


Advanced Ingredient Data


Raw Label Data

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