Bc0964

Bc0964
SPL v2
SPL
SPL Set ID ffa6ddc5-4017-4eb9-8887-5f7c7d1f5525
Route
TOPICAL
Published
Effective Date 2012-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.675 g) Oxybenzone (2.45 g) Octisalate (1.078 g) Octocrylene (0.98 g) Avobenzone
Inactive Ingredients
Water Dimethicone Alkyl (c12-15) Benzoate Butylene Glycol Cyclomethicone 5 Isostearyl Neopentanoate Cocoa Butter Sheanut Oil Ppg-2 Isoceteth-20 Acetate Glycerin Medium-chain Triglycerides Ceramide 1 Ceramide 3 Ceramide 6 Ii Alpinia Zerumbet Leaf Abelmoschus Moschatus Seed Trifolium Pratense Flower Hyaluronate Sodium Ascorbyl Palmitate Retinyl Linoleate Vitamin A Palmitate Tocopherol .alpha.-tocopherol Acetate Isohexadecane Propylene Glycol Sodium Pyrrolidone Carboxylate Trehalose Urea Hydrogenated Soybean Lecithin Lecithin, Soybean Omega-3 Fatty Acids Phytosphingosine Sucrose Cetostearyl Alcohol Cholesterol Sodium Lauroyl Lactylate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polysorbate 80 Trideceth-6 Polyethylene Glycol 400 Xanthan Gum Sodium Hydroxide Butylated Hydroxytoluene Mineral Oil Phenyl Trimethicone Isomethyl-.alpha.-ionone Benzyl Benzoate Butylphenyl Methylpropional Citral .beta.-citronellol, (r)- Eugenol Geraniol .alpha.-hexylcinnamaldehyde Hydroxyisohexyl 3-cyclohexene Carboxaldehyde Benzoic Acid Butylparaben Ethylparaben Isobutylparaben Methylparaben Phenoxyethanol Potassium Sorbate Propylparaben Chlorphenesin Fd&c Red No. 4 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-02-27

Description

A moisture treatment for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Hydrates intensely throughout the day, leaving skin feeling softer and firmer. Diminishes the appearance of surface lines and targets deeper wrinkles. Helps restore radiance for a more youthful looking complexion.

Indications and Usage

To Use: Apply to cleansed skin after Ceramide Capsules in the morning. Directions for Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least ever 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.. Wear long-sleeve shirts, pants, hats, and sunglasses.

Purpose

Provides SPF 30 sun protection.


Medication Information

Indications and Usage

To Use: Apply to cleansed skin after Ceramide Capsules in the morning.

Directions for Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least ever 2 hours.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.. Wear long-sleeve shirts, pants, hats, and sunglasses.

Purpose

Provides SPF 30 sun protection.

Description

A moisture treatment for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Hydrates intensely throughout the day, leaving skin feeling softer and firmer. Diminishes the appearance of surface lines and targets deeper wrinkles. Helps restore radiance for a more youthful looking complexion.

Section 51945-4

Warnings

Warnings:

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Otc Purpose

Provides SPF 30 sun protection.

Otc When Using

Keep out of eyes.

Inactive Ingredient

Other Ingredients: Water/Aqua/Eau, Dimethicone, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isostearyl Neopentanoate, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone/Vinyl Cimethicon Crosspolymer, Butyrospermum Parkii (Shea Butter) Extract, PPG-2 Isoceteth-20 Acetate, Glycerin Caprylic/Capric Triglyceride, Ceramide 1, Ceramide 3, Ceramide 6 II, Apinia Speciosa Leaf Extract, Hibiscus Abelmoschuss Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl Linoleate Retinyl Plamitate, Tocopherol, Tocopheryl Acetate, Cetearyl Dimethicon Crosspolymer, Isohexadecane, Acetyo Octapeptide-3, Propylene Glycol, Sodium PCA, Trehalose Urea, Hydrogenated Lecithin, Lecithin Phopholipids, Phytosphingosing, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearly Alcohol, Cholesterorl, Sodium lauroyl Lactylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, Trideceth-6, Acrylamide/Sodium Acrylate Copolymer, Polyquaternium-51, PEG-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Sodium Hydroxide, BHT, Mineral Oil/Paraddinum Liquid/Huile Minerale, Dimethiconol. Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Butylphenyl Metyhlpropional, Citral, Citronellol, Eugenol, Geraniol, Hexyl Cinnamal Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Chlorphenesin, Red 4 (CI 14700), Yellow 6 (CI15985).

Dosage & Administration

Apply to skin.

Otc Active Ingredient

Active Ingredients: Octinoxate 7.5 %, Oxybenzone 5.0%, Octisalate 5.0%, Octocrylene 2.2%, Avobenzone 2.0%.

Otc Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center immediately.


Structured Label Content

Section 51945-4 (51945-4)

Warnings (WARNINGS)

Warnings:

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Description (DESCRIPTION)

A moisture treatment for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Hydrates intensely throughout the day, leaving skin feeling softer and firmer. Diminishes the appearance of surface lines and targets deeper wrinkles. Helps restore radiance for a more youthful looking complexion.

Otc Purpose (OTC - PURPOSE)

Provides SPF 30 sun protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Other Ingredients: Water/Aqua/Eau, Dimethicone, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isostearyl Neopentanoate, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone/Vinyl Cimethicon Crosspolymer, Butyrospermum Parkii (Shea Butter) Extract, PPG-2 Isoceteth-20 Acetate, Glycerin Caprylic/Capric Triglyceride, Ceramide 1, Ceramide 3, Ceramide 6 II, Apinia Speciosa Leaf Extract, Hibiscus Abelmoschuss Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl Linoleate Retinyl Plamitate, Tocopherol, Tocopheryl Acetate, Cetearyl Dimethicon Crosspolymer, Isohexadecane, Acetyo Octapeptide-3, Propylene Glycol, Sodium PCA, Trehalose Urea, Hydrogenated Lecithin, Lecithin Phopholipids, Phytosphingosing, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearly Alcohol, Cholesterorl, Sodium lauroyl Lactylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, Trideceth-6, Acrylamide/Sodium Acrylate Copolymer, Polyquaternium-51, PEG-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Sodium Hydroxide, BHT, Mineral Oil/Paraddinum Liquid/Huile Minerale, Dimethiconol. Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Butylphenyl Metyhlpropional, Citral, Citronellol, Eugenol, Geraniol, Hexyl Cinnamal Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Chlorphenesin, Red 4 (CI 14700), Yellow 6 (CI15985).

Indications and Usage (INDICATIONS AND USAGE)

To Use: Apply to cleansed skin after Ceramide Capsules in the morning.

Directions for Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least ever 2 hours.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.. Wear long-sleeve shirts, pants, hats, and sunglasses.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Apply to skin.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate 7.5 %, Oxybenzone 5.0%, Octisalate 5.0%, Octocrylene 2.2%, Avobenzone 2.0%.

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center immediately.


Advanced Ingredient Data


Raw Label Data

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