SPL v1
SPL
SPL Set ID b9a7bf86-4c96-4545-971e-8c6cd973c217
Route
TOPICAL
Published
Effective Date 2020-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.50 g) Titanium Dioxide (4.41 g) Zinc Cation (2.00 g)
Inactive Ingredients
Glycerin Diisostearyl Malate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-12-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7%, Titanium Dioxide 8.83%, Zinc Oxide 4.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

High coverage Snail Blemish Balm for brighter and more radiant skin. Helps prevent sunburn.

Directions:

Take moderate amount and apply evenly over entire face at the last step in skin care.

Warnings

Warnings:

1)In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

2) Do not apply on broken skin or wounded areas.

3) Precautions for storage and handling

A) Keep out of reach of children.

B) Store away from direct sunlight.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7%, Titanium Dioxide 8.83%, Zinc Oxide 4.00%

Inactive Ingredient

Inactive ingredients:

Snail Secretion Filtrate, Cyclopentasiloxane, Glycerin, Diisostearyl Malate, Phenyl Trimethicone, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Niacinamide, Cyclomethicone, Sodium Chloride, Trimethylsiloxyphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Sorbitan Sesquioleate, Polyethylene, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Adenosine, Disodium EDTA, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Phenoxyethanol

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

1)In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

2) Do not apply on broken skin or wounded areas.

3) Precautions for storage and handling

A) Keep out of reach of children.

B) Store away from direct sunlight.

Description (DESCRIPTION)

Uses:

High coverage Snail Blemish Balm for brighter and more radiant skin. Helps prevent sunburn.

Directions:

Take moderate amount and apply evenly over entire face at the last step in skin care.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7%, Titanium Dioxide 8.83%, Zinc Oxide 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Snail Secretion Filtrate, Cyclopentasiloxane, Glycerin, Diisostearyl Malate, Phenyl Trimethicone, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Niacinamide, Cyclomethicone, Sodium Chloride, Trimethylsiloxyphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Sorbitan Sesquioleate, Polyethylene, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Adenosine, Disodium EDTA, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Phenoxyethanol

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


Advanced Ingredient Data


Raw Label Data

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