SPL v1
SPL
SPL Set ID fe06a496-9627-49f7-820d-7d3eb7d30b79
Route
TOPICAL
Published
Effective Date 2014-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 mg) Octisalate (2.5 mg) Octocrylene (2 mg) Avobenzone (1.5 mg)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-01

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Octocrylene 4%, Butyl Methoxydibenzoylmethane 3%

Purpose

Purpose: Sun Protective Lotion


Medication Information

Purpose

Purpose: Sun Protective Lotion

Description

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Octocrylene 4%, Butyl Methoxydibenzoylmethane 3%

Warnings

Warnings:

Store in a cool environment.

Avoid contact with eyes.

In case of contact with eyes, rinse thoroughly with water.

If you experience any discomfort or allergic reaction after use, cease use immediately and consult with a doctor or skincare professional.

For external use only.

Active Ingredient

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Octocrylene 4%, Butyl Methoxydibenzoylmethane 3%

Inactive Ingredient

INACTIVE INGREDIENTS:

AQUA, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, CAPRYLIC/ CAPRIC TRIGLYCERIDE, NIACINAMIDE, GLYCERYL STEARATE, CETEARYL OLIVATE, CETEARYL ALCOHOL, SORBITAN OLIVATE, DIMETHICONE, PEG-100 STEARATE, POLY-SORBATE 60, NELUMBO NUCIFERA CALLUS CULTURE EXTRACT, XANTHAN GUM, PHENOXYETHANOL, TOCOPHERYL ACETATE, FRAGRANCE, SODIUM BENZOATE, POLYACRYLATE-13, SORBITAN STEARATE, DISODIUM EDTA, ROYAL JELLY EXTRACT, PEARL EXTRACT, GLYCERIN, POLYISOBUTENE, POTASSIUM SORBATE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, BHT, PROPYLENE GLYCOL, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EQUISETUM ARVENSE EXTRACT, ADANSONIA DIGITATA SEED EXTRACT, SORBITAN ISOSTEARATE, POLYSORBATE 20, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, VERONICA OFFICINALIS EXTRACT, PRIMULA VERIS EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, MALVA SYLVESTRIS (MALLOW) EXTRACT, ALCHEMILLA VULGARIS EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, SODIUM HYALURONATE, FRUCTAN, CAPRYLYL GLYCOL, ACETYL TYROSINE, 1,2- HEXANEDIOL, PAEONIA SUFFRUTICOSA ROOT EXTRACT, PUERARIA LOBATA ROOT EXTRACT, ETHYLHEXYLGLYCERIN

Indications and Usage

Indications and usage:

After cleansing and toning regimen, apply a small amount onto face and neck area before exposing to outdoor sunlight, avoiding eye area.

For optimal results, use after Ultimate Aqua Blanc Concentrate for an enhanced brightened complexion.

Dosage and Administration

Dosage and administration:

Take an adequate amount of this product.

Keep Out of Reach of Children

Keep out of reach of children.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sun Protective Lotion

Warnings (WARNINGS)

Warnings:

Store in a cool environment.

Avoid contact with eyes.

In case of contact with eyes, rinse thoroughly with water.

If you experience any discomfort or allergic reaction after use, cease use immediately and consult with a doctor or skincare professional.

For external use only.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Octocrylene 4%, Butyl Methoxydibenzoylmethane 3%

Inactive Ingredient (INACTIVE INGREDIENT)

INACTIVE INGREDIENTS:

AQUA, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, CAPRYLIC/ CAPRIC TRIGLYCERIDE, NIACINAMIDE, GLYCERYL STEARATE, CETEARYL OLIVATE, CETEARYL ALCOHOL, SORBITAN OLIVATE, DIMETHICONE, PEG-100 STEARATE, POLY-SORBATE 60, NELUMBO NUCIFERA CALLUS CULTURE EXTRACT, XANTHAN GUM, PHENOXYETHANOL, TOCOPHERYL ACETATE, FRAGRANCE, SODIUM BENZOATE, POLYACRYLATE-13, SORBITAN STEARATE, DISODIUM EDTA, ROYAL JELLY EXTRACT, PEARL EXTRACT, GLYCERIN, POLYISOBUTENE, POTASSIUM SORBATE, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, BHT, PROPYLENE GLYCOL, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, EQUISETUM ARVENSE EXTRACT, ADANSONIA DIGITATA SEED EXTRACT, SORBITAN ISOSTEARATE, POLYSORBATE 20, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, VERONICA OFFICINALIS EXTRACT, PRIMULA VERIS EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, MALVA SYLVESTRIS (MALLOW) EXTRACT, ALCHEMILLA VULGARIS EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, SOPHORA JAPONICA FLOWER EXTRACT, SODIUM HYALURONATE, FRUCTAN, CAPRYLYL GLYCOL, ACETYL TYROSINE, 1,2- HEXANEDIOL, PAEONIA SUFFRUTICOSA ROOT EXTRACT, PUERARIA LOBATA ROOT EXTRACT, ETHYLHEXYLGLYCERIN

Indications and Usage (INDICATIONS AND USAGE)

Indications and usage:

After cleansing and toning regimen, apply a small amount onto face and neck area before exposing to outdoor sunlight, avoiding eye area.

For optimal results, use after Ultimate Aqua Blanc Concentrate for an enhanced brightened complexion.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and administration:

Take an adequate amount of this product.

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

Keep out of reach of children.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)