SPL v1
SPL
SPL Set ID 8ae9b5f1-050e-4a71-addd-0e578f797714
Route
TOPICAL
Published
Effective Date 2014-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 mg)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-01

Description

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Purpose

Purpose: UVA/UVB Protection


Medication Information

Purpose

Purpose: UVA/UVB Protection

Description

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Warnings

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product.

4. Keep away from direct sunlight or heat.

5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards.

Active Ingredient

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Inactive Ingredient

Inactive Ingredients:

WATER, GLYCERIN, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DICAPRYLYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, POLYSORBATE 60, CYCLOMETHICONE, TITANIUM DIOXIDE, SILICA, ALUMINA, STEARIC ACID, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, SORBITAN SESQUIOLEATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHERYL ACETATE, BETA GLUCAN, PORTULACA OLERACEA EXTRACT, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, DISODIUM EDTA, PHENOXYETHANOL, METHYL PARABEN, PROPYL PARABEN, FRAGRANCE

Indications and Usage

Indication and Usage:

At your final skin care step, apply it to your whole face with the proper amount after all your basic skin care.

If you feel more perfect UV protect effect, apply it more whenever needed.

Dosage and Administration

Dosage and Administration:

Release an appropriate amount and evenly spread over face and body with gentle patting.

Keep Out of Reach of Children

Keep out of reach of children:

Keep out of reach of babies and children

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: UVA/UVB Protection

Warnings (WARNINGS)

Warnings:

1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product.

4. Keep away from direct sunlight or heat.

5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

WATER, GLYCERIN, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DICAPRYLYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, POLYSORBATE 60, CYCLOMETHICONE, TITANIUM DIOXIDE, SILICA, ALUMINA, STEARIC ACID, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, SORBITAN SESQUIOLEATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHERYL ACETATE, BETA GLUCAN, PORTULACA OLERACEA EXTRACT, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, DISODIUM EDTA, PHENOXYETHANOL, METHYL PARABEN, PROPYL PARABEN, FRAGRANCE

Indications and Usage (INDICATIONS AND USAGE)

Indication and Usage:

At your final skin care step, apply it to your whole face with the proper amount after all your basic skin care.

If you feel more perfect UV protect effect, apply it more whenever needed.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and Administration:

Release an appropriate amount and evenly spread over face and body with gentle patting.

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

Keep out of reach of children:

Keep out of 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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