SPL v1
SPL
SPL Set ID 534501d7-2838-4860-be93-67a022db0739
Route
TOPICAL
Published
Effective Date 2012-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3.89 g) Octinoxate (2.66 g) Octisalate (0.76 g)
Inactive Ingredients
Water Cyclomethicone Glycereth-26 Niacinamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-01

Description

ACTIVE INGREDIENTS: Zinc Oxide 10.24%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 2.00%

Indications and Usage

INDICATION AND USAGE: At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed. Reapply during long exposure.

Purpose

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Dosage and Administration

DOSAGE AND ADMINISTRATION: Take appropriate amount according to your skin condition and apply every morning and night.


Medication Information

Indications and Usage

INDICATION AND USAGE:

At the last step of basic skin care, apply an appropriate amount evenly over the face.

Pat lightly until fully absorbed.

Reapply during long exposure.

Purpose

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Dosage and Administration

DOSAGE AND ADMINISTRATION: Take appropriate amount according to your skin condition and apply every morning and night.

Description

ACTIVE INGREDIENTS: Zinc Oxide 10.24%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 2.00%

Warnings

WARNING:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not use on wounds or if you are allergic to any ingredients of this product.

Active Ingredient

ACTIVE INGREDIENTS: Zinc Oxide 10.24%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 2.00%

Inactive Ingredient

INACTIVE INGREDIENTS : Water, Cyclomethicone, Glycereth-26, Jasminum Officinale (Jasmine) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Freesia Alba Flower Extract, Niacinamide, Saussurea Involucrata Extract, Bellis Perennis (Daisy) Flower Extract, Lilium Candidum Flower Extract, Houttuynia Cordata Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Betaine, Gnaphalium Leontopodium Flower Extract, Sea Water, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cassia Alata Leaf Extract, Sigesbeckia Orientalis Extract, Rabdosia Rubescens Extract, Glucose, Methoxy PEG-45 Thioctate, Buddleja Axillaris Leaf Extract, Fullerenes, Glyceryl Diisostearate, PEG-7 Dimethicone, C12-15 Alkyl Benzoate, Ethyl Hexanediol, Distearyldimonium Chloride, PEG-30 Dipolyhydroxystearate, Polymethyl Methacrylate, Dimethicone/Methicone Copolymer, Beeswax, Sorbitan Oleate, Glyceryl Caprylate, Iron Oxides, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Octyldodecanol, BHT, Methicone, Sodium C14-17 Alkyl Sec Sulfonate, Copper Sulfate, Polyacrylic Acid, Butylene Glycol, PVP, Fragrance, Butylphenyl Methylpropional, Eugenol

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel


Structured Label Content

Purpose (PURPOSE)

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

Warnings (WARNINGS)

WARNING:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not use on wounds or if you are allergic to any ingredients of this product.

Active Ingredient (ACTIVE INGREDIENT)

ACTIVE INGREDIENTS: Zinc Oxide 10.24%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 2.00%

Inactive Ingredient (INACTIVE INGREDIENT)

INACTIVE INGREDIENTS : Water, Cyclomethicone, Glycereth-26, Jasminum Officinale (Jasmine) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Freesia Alba Flower Extract, Niacinamide, Saussurea Involucrata Extract, Bellis Perennis (Daisy) Flower Extract, Lilium Candidum Flower Extract, Houttuynia Cordata Extract, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Betaine, Gnaphalium Leontopodium Flower Extract, Sea Water, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cassia Alata Leaf Extract, Sigesbeckia Orientalis Extract, Rabdosia Rubescens Extract, Glucose, Methoxy PEG-45 Thioctate, Buddleja Axillaris Leaf Extract, Fullerenes, Glyceryl Diisostearate, PEG-7 Dimethicone, C12-15 Alkyl Benzoate, Ethyl Hexanediol, Distearyldimonium Chloride, PEG-30 Dipolyhydroxystearate, Polymethyl Methacrylate, Dimethicone/Methicone Copolymer, Beeswax, Sorbitan Oleate, Glyceryl Caprylate, Iron Oxides, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Octyldodecanol, BHT, Methicone, Sodium C14-17 Alkyl Sec Sulfonate, Copper Sulfate, Polyacrylic Acid, Butylene Glycol, PVP, Fragrance, Butylphenyl Methylpropional, Eugenol

Indications and Usage (INDICATIONS AND USAGE)

INDICATION AND USAGE:

At the last step of basic skin care, apply an appropriate amount evenly over the face.

Pat lightly until fully absorbed.

Reapply during long exposure.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

DOSAGE AND ADMINISTRATION: Take appropriate amount according to your skin condition and apply every morning and night.

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

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