SPL v1
SPL
SPL Set ID 6f9d3195-418d-446e-817c-e0fddb68ee14
Route
TOPICAL
Published
Effective Date 2013-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.75 g) Octisalate (2.5 g) Ensulizole (2 g) Avobenzone (1.5 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-01

Description

Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

Purpose

Purpose : Sunscreen


Medication Information

Purpose

Purpose : Sunscreen

Description

Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

Warnings

Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

Active Ingredient

Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

Inactive Ingredient

Inactive ingredient : WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ARBUTIN, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CETEARYL OLIVATE, GLYCERIN, SORBITAN OLIVATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE, SODIUM HYDROXIDE, DIMETHICONE, PANTHENOL, METHYL METHACRYLATE CROSSPOLYMER, VP/HEXADECENE COPOLYMER, POLYSORBATE 60, POLYACRYLATE-13, PHENOXYETHANOL, SORBITAN STEARATE, POLYISOBUTENE, DISODIUM EDTA, TOCOPHERYL ACETATE, SODIUM BENZOATE, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, PEG-100 STEARATE, POTASSIUM SORBATE, CITRUS AURANTIFOLIA (LIME) FLOWER EXTRACT, ADENOSINE, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, BHT, SORBITAN ISOSTEARATE, POLYSORBATE 20, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PYRUS MALUS (APPLE) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, 1,2-HEXANDIOL, CAPRYLYL GLYCOL, CITRUS AURANTIFOLIA (LIME) OIL, PUNICA GRANATUM FLOWER EXTRACT, PINUS SYLVESTRIS LEAF OIL, PRUNUS AVIUM (SWEET CHERRY) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER EXTRACT, HYDROLYZED EXTENSIN, ALOE BARBADENSIS LEAF JUICE, EUCALYPTUS GLOBULUS LEAF OIL, ZEA MAYS (CORN) KERNEL EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, SQUALANE, PHOSPHOLIPIDS, CI 17200, PHYTOSPHINGOSINE, CERAMIDE 3, TROPOLONE, PHYTOSTEROLS, ETHYLHEXYLGLYCERIN

Indications and Usage

Indications and usage : At the last step of basic skin care, take a proper amount of the sun block and spread it evenly over the skin.

Dosage and Administration

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

Keep Out of Reach of Children

Keep out of reach of children and babies.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose : Sunscreen

Warnings (WARNINGS)

Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredient : WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ARBUTIN, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CETEARYL OLIVATE, GLYCERIN, SORBITAN OLIVATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE, SODIUM HYDROXIDE, DIMETHICONE, PANTHENOL, METHYL METHACRYLATE CROSSPOLYMER, VP/HEXADECENE COPOLYMER, POLYSORBATE 60, POLYACRYLATE-13, PHENOXYETHANOL, SORBITAN STEARATE, POLYISOBUTENE, DISODIUM EDTA, TOCOPHERYL ACETATE, SODIUM BENZOATE, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, PEG-100 STEARATE, POTASSIUM SORBATE, CITRUS AURANTIFOLIA (LIME) FLOWER EXTRACT, ADENOSINE, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, BHT, SORBITAN ISOSTEARATE, POLYSORBATE 20, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PYRUS MALUS (APPLE) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, 1,2-HEXANDIOL, CAPRYLYL GLYCOL, CITRUS AURANTIFOLIA (LIME) OIL, PUNICA GRANATUM FLOWER EXTRACT, PINUS SYLVESTRIS LEAF OIL, PRUNUS AVIUM (SWEET CHERRY) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER EXTRACT, HYDROLYZED EXTENSIN, ALOE BARBADENSIS LEAF JUICE, EUCALYPTUS GLOBULUS LEAF OIL, ZEA MAYS (CORN) KERNEL EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, SQUALANE, PHOSPHOLIPIDS, CI 17200, PHYTOSPHINGOSINE, CERAMIDE 3, TROPOLONE, PHYTOSTEROLS, ETHYLHEXYLGLYCERIN

Indications and Usage (INDICATIONS AND USAGE)

Indications and usage : At the last step of basic skin care, take a proper amount of the sun block and spread it evenly over the skin.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

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

Keep out of reach of children and babies.

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


Advanced Ingredient Data


Raw Label Data

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