a6491fc7-61db-40cc-bcc5-19da06b7fe99

SPL v1
SPL
SPL Set ID a6491fc7-61db-40cc-bcc5-19da06b7fe99
Route
topical
Published
Effective Date 2016-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (0.11 g)
Inactive Ingredients
isoamyl laurate ceresin

Identifiers & Packaging

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

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Titanium Dioxide 11.0%


Medication Information

Purpose

Purpose: Sunscreen

Description

INSTRUCTIONS: Powdery finish matte lip crayon adheres smoothly onto your lips and imparts a non-oily finish for a chic look.

Directions: Glide across the entire lip with powdery finish matte lip crayon and apply it again to the center of your lips to get voluminous and fuller lips

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 11.0%

Inactive Ingredient

Inactive Ingredients: Isoamyl Laurate, Polyglyceryl-2 Triisostearate, Ceresin, Mica, Silica, Euphorbia Cerifera (Candelilla) Wax, Polyethylene, Iron Oxides (CI 77491), Dimethicone, Red 6 (CI 15850), Dimethicone/Vinyl DimethiconeCrosspolymer, Yellow 5 Lake (CI 19140), Iron Oxides (CI 77499), Propylparaben, SimmondsiaChinensis (Jojoba) Seed Oil, PerseaGratissima (Avocado) Oil

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

INSTRUCTIONS: Powdery finish matte lip crayon adheres smoothly onto your lips and imparts a non-oily finish for a chic look.

Directions: Glide across the entire lip with powdery finish matte lip crayon and apply it again to the center of your lips to get voluminous and fuller lips

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 11.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Isoamyl Laurate, Polyglyceryl-2 Triisostearate, Ceresin, Mica, Silica, Euphorbia Cerifera (Candelilla) Wax, Polyethylene, Iron Oxides (CI 77491), Dimethicone, Red 6 (CI 15850), Dimethicone/Vinyl DimethiconeCrosspolymer, Yellow 5 Lake (CI 19140), Iron Oxides (CI 77499), Propylparaben, SimmondsiaChinensis (Jojoba) Seed Oil, PerseaGratissima (Avocado) Oil

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


Advanced Ingredient Data


Raw Label Data

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