SPL v1
SPL
SPL Set ID 7bea7d8a-b868-4163-ac04-459159e71e9e
Route
TOPICAL
Published
Effective Date 2014-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.13 g) Zinc Cation (1.66 g) Octinoxate (1.54 g)
Inactive Ingredients
Mica Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-30

Description

Active ingredients: Titanium Dioxide 9.7%, Zinc Oxide 7.55%, Ethylhexyl Methoxycinnamate 7%

Purpose

Purpose: UVA/UVB Protection


Medication Information

Purpose

Purpose: UVA/UVB Protection

Description

Active ingredients: Titanium Dioxide 9.7%, Zinc Oxide 7.55%, Ethylhexyl Methoxycinnamate 7%

Warnings

Warnings:

1. When the use of this cosmetic product causes the following side effects, you should stop using it. If you continue to use it, those side effects can worsen. So, you should consult a dermatologist about them.

a. Side effects such as red spots, swelling, pruritus and stimulation can occur when using this product.

b. The above side effects can occur on the applied part due to direct sunlight.

2. Please do not put this cosmetic product on wounded or damaged skin due to eczema and dermatitis.

3. When it gets into your eyes, please wash it off immediately with clean water.

Active Ingredient

Active ingredients: Titanium Dioxide 9.7%, Zinc Oxide 7.55%, Ethylhexyl Methoxycinnamate 7%

Inactive Ingredient

Inactive ingredients:

Cetyl Ethylhexanoate, Mica, Hexyl Laurate, Phenyl Trimethicone, Dimethicone, Methyl Methacrylate Crosspolymer, Nylon-12, Synthetic Wax, Ceresin, Ricinus Communis (Castor) Seed Oil, Sorbitan Olivate, Cetyl Palmitate, Ethylene/Propylene Copolymer, Sorbitan Sesquioleate,

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sorbitan Palmitate, Sorbitan Stearate, sucrose distearate, Stearalkonium Hectorite, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Propylene Carbonate, Tocopheryl Acetate, Tropolone, BHT, CI 77492, Argania Spinosa Kernel Oil, Zizania Aquatica Extract, CI 77491, Amber Powder, Amethyst Powder, Nephrite Powder, Pearl Powder, Tourmaline, Ruby Powder, Phenoxyethanol

Indications & Usage

Indication and usage:

Please close the cap after use. Once it is unpacked, please use them up immediately as it dries up quickly.

Please do not keep this product in places with very high or low temperatures.

And please keep it out of direct sunlight.

Dosage & Administration

Dosage and administration:

After using basic goods, apply the product to forehead and nose in T shape, and cheeks in U shape. Then spread evenly with fingers and pat.

Keep Out of Reach of Children

Keep out of reach of children:

Please keep this product out of the reach of babies and children.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: UVA/UVB Protection

Warnings (WARNINGS)

Warnings:

1. When the use of this cosmetic product causes the following side effects, you should stop using it. If you continue to use it, those side effects can worsen. So, you should consult a dermatologist about them.

a. Side effects such as red spots, swelling, pruritus and stimulation can occur when using this product.

b. The above side effects can occur on the applied part due to direct sunlight.

2. Please do not put this cosmetic product on wounded or damaged skin due to eczema and dermatitis.

3. When it gets into your eyes, please wash it off immediately with clean water.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 9.7%, Zinc Oxide 7.55%, Ethylhexyl Methoxycinnamate 7%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Cetyl Ethylhexanoate, Mica, Hexyl Laurate, Phenyl Trimethicone, Dimethicone, Methyl Methacrylate Crosspolymer, Nylon-12, Synthetic Wax, Ceresin, Ricinus Communis (Castor) Seed Oil, Sorbitan Olivate, Cetyl Palmitate, Ethylene/Propylene Copolymer, Sorbitan Sesquioleate,

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sorbitan Palmitate, Sorbitan Stearate, sucrose distearate, Stearalkonium Hectorite, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Propylene Carbonate, Tocopheryl Acetate, Tropolone, BHT, CI 77492, Argania Spinosa Kernel Oil, Zizania Aquatica Extract, CI 77491, Amber Powder, Amethyst Powder, Nephrite Powder, Pearl Powder, Tourmaline, Ruby Powder, Phenoxyethanol

Indications & Usage (INDICATIONS & USAGE)

Indication and usage:

Please close the cap after use. Once it is unpacked, please use them up immediately as it dries up quickly.

Please do not keep this product in places with very high or low temperatures.

And please keep it out of direct sunlight.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage and administration:

After using basic goods, apply the product to forehead and nose in T shape, and cheeks in U shape. Then spread evenly with fingers and pat.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children:

Please keep this product out of the reach of babies and children.

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


Advanced Ingredient Data


Raw Label Data

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