SPL v2
SPL
SPL Set ID bae9b2e0-a435-4343-91e7-d6fb6df11bd1
Route
TOPICAL
Published
Effective Date 2014-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 mg)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-02

Description

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Indications and Usage

INDICATIONS AND USAGE: In the last step of skin care, spread it softly on the whole face. Beside the face, you can use it on any area if you think sunscreen needed.

Purpose

PURPOSE: UVA/UVB Protection


Medication Information

Indications and Usage

INDICATIONS AND USAGE:

In the last step of skin care, spread it softly on the whole face.

Beside the face, you can use it on any area if you think sunscreen needed.

Purpose

PURPOSE: UVA/UVB Protection

Description

Active Ingredient: 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.

Active Ingredient

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Inactive Ingredient

Inactive Ingredients:

WATER, BUTYLENE GLYCOL, ALCOHOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ISOAMYL p-METHOXYCINNAMATE, TREHALOSE, TITANIUM DIOXIDE, CYCLOPENTASILOXANE, HEXYL LAURATE, PEG-10, DIMETHICONE, STEARIC ACID, ALUMINA, PEG, PPG-17, 6COPOLYMER, SODIUM HYALURONATE, CAPRYLYL GLYCOL, ETHYLHEXYL GLYCERIN, TROPOLONE, TRIETHANOLAMINE, CARBOMER, ACRYLATES/C10-30 ALKLY ACRYLATE CROSSPOLYMER, CYMBOPOGON SCHOENANTHUS OIL, EUCALYPTUS GLOBULUS LEAF OIL, JUNIPERUS MEXICANA OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, CANANGA ODORATA FLOWER OIL, GLYCERINE, RUBUS CHAMAEMORUS SEED EXTRACT, ANASTATICA HIEROCHUNTICA (ROSE OF JERICHO) EXTRACT, COLLAGEN, COPPER TRIPEPTIDE-1, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, CONVALLARIA MAJALIS BULB/ROOT EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, HONEY EXTRACT, PROPYLENE GLYCOL, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, VACCINUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, SAMBUCUS NIGRA FRUIT EXTRACT, DEXTRAN, TRIFLUOROACETYL TRIPEPTIDE-2, SILICA, PANTETHINE, DISODIUM EDTA

Dosage and Administration

DOSAGE AND ADMINISTRATION:

Apply an appropriate amount onto your skin. Tap applied face softly for better absorption.

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.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

WATER, BUTYLENE GLYCOL, ALCOHOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ISOAMYL p-METHOXYCINNAMATE, TREHALOSE, TITANIUM DIOXIDE, CYCLOPENTASILOXANE, HEXYL LAURATE, PEG-10, DIMETHICONE, STEARIC ACID, ALUMINA, PEG, PPG-17, 6COPOLYMER, SODIUM HYALURONATE, CAPRYLYL GLYCOL, ETHYLHEXYL GLYCERIN, TROPOLONE, TRIETHANOLAMINE, CARBOMER, ACRYLATES/C10-30 ALKLY ACRYLATE CROSSPOLYMER, CYMBOPOGON SCHOENANTHUS OIL, EUCALYPTUS GLOBULUS LEAF OIL, JUNIPERUS MEXICANA OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, CANANGA ODORATA FLOWER OIL, GLYCERINE, RUBUS CHAMAEMORUS SEED EXTRACT, ANASTATICA HIEROCHUNTICA (ROSE OF JERICHO) EXTRACT, COLLAGEN, COPPER TRIPEPTIDE-1, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, CONVALLARIA MAJALIS BULB/ROOT EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, HONEY EXTRACT, PROPYLENE GLYCOL, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, VACCINUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, SAMBUCUS NIGRA FRUIT EXTRACT, DEXTRAN, TRIFLUOROACETYL TRIPEPTIDE-2, SILICA, PANTETHINE, DISODIUM EDTA

Indications and Usage (INDICATIONS AND USAGE)

INDICATIONS AND USAGE:

In the last step of skin care, spread it softly on the whole face.

Beside the face, you can use it on any area if you think sunscreen needed.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

DOSAGE AND ADMINISTRATION:

Apply an appropriate amount onto your skin. Tap applied face softly for better absorption.

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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