68142ea0-c279-4942-8445-a7b8f44be2e5

SPL v1
SPL
SPL Set ID 68142ea0-c279-4942-8445-a7b8f44be2e5
Route
topical
Published
Effective Date 2016-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (1.03 g)
Inactive Ingredients
talc mica

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-08-10

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Titanium Dioxide 9.4%


Medication Information

Purpose

Purpose: Sunscreen

Description

INSTRUCTIONS: Face maker contours the face by creating natural-looking shadow.

Directions: For shading, begin from the outer part of your chin then continue to inner part. For highlighting, apply on your T-zone, eye bags, tip of your chin.

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 9.4%

Inactive Ingredient

Inactive Ingredients:

A) Talc, Mica (CI 77019), OctyldodecylStearoyl Stearate, Phenyl Trimethicone, Nylon-12, Silica, Magnesium Myristate, Magnesium Stearate, Caprylic/Capric Triglyceride, Dimethiconol Stearate, Methylparaben, Dimethicone, Methicone, Tin Oxide (CI 77861), Tocopheryl Acetate, Yellow 5 Lake (CI 19140), Propylparaben, Red 30 (CI 73360), Iron Oxides (CI 77499)

B) Talc, Mica (CI 77019), Nylon-12, OctyldodecylStearoyl Stearate, Phenyl Trimethicone, Titanium Dioxide (CI 77891), Silica, Magnesium Myristate, Iron Oxides (CI 77492), Iron Oxides (CI 77499), Iron Oxides (CI 77491), Caprylic/Capric Triglyceride, Magnesium Stearate, Dimethicone, Dimethiconol Stearate, Methicone, Methylparaben, Tocopheryl Acetate, Propylparaben

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

INSTRUCTIONS: Face maker contours the face by creating natural-looking shadow.

Directions: For shading, begin from the outer part of your chin then continue to inner part. For highlighting, apply on your T-zone, eye bags, tip of your chin.

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

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 9.4%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

A) Talc, Mica (CI 77019), OctyldodecylStearoyl Stearate, Phenyl Trimethicone, Nylon-12, Silica, Magnesium Myristate, Magnesium Stearate, Caprylic/Capric Triglyceride, Dimethiconol Stearate, Methylparaben, Dimethicone, Methicone, Tin Oxide (CI 77861), Tocopheryl Acetate, Yellow 5 Lake (CI 19140), Propylparaben, Red 30 (CI 73360), Iron Oxides (CI 77499)

B) Talc, Mica (CI 77019), Nylon-12, OctyldodecylStearoyl Stearate, Phenyl Trimethicone, Titanium Dioxide (CI 77891), Silica, Magnesium Myristate, Iron Oxides (CI 77492), Iron Oxides (CI 77499), Iron Oxides (CI 77491), Caprylic/Capric Triglyceride, Magnesium Stearate, Dimethicone, Dimethiconol Stearate, Methicone, Methylparaben, Tocopheryl Acetate, Propylparaben

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


Advanced Ingredient Data


Raw Label Data

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