Bb0802

Bb0802
SPL v2
SPL
SPL Set ID e117e9b7-eead-49de-8e5e-a4f29580bb81
Route
TOPICAL
Published
Effective Date 2012-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Oxybenzone (2.5 g) Octisalate (1 g) Avobenzone
Inactive Ingredients
Water Butylene Glycol Alkyl (c12-15) Benzoate Cyclomethicone 5 Cetostearyl Alcohol Dimethicone Glycerin Cocoa Butter Shea Butter Caprylyl Trisiloxane 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 Hydrogenated Palm Glycerides Isohexadecane Propylene Glycol Sodium Pyrrolidone Carboxylate Trehalose Urea Hydrogenated Soybean Lecithin Egg Phospholipids Omega-3 Fatty Acids Phytosphingosine Sucrose Cholesterol Sodium Lauroyl Lactylate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Peg-8 Laurate Polysorbate 80 Potassium Cetyl Phosphate Sodium Dodecylbenzenesulfonate Xanthan Gum Sodium Hydroxide Butylated Hydroxytoluene Phenyl Trimethicone Isomethyl-.alpha.-ionone Benzyl Benzoate Butylphenyl Methylpropional Citral Eugenol Geraniol .alpha.-hexylcinnamaldehyde Hydroxyisohexyl 3-cyclohexene Carboxaldehyde Benzoic Acid Butylparaben Ethylparaben Isobutylparaben Methylparaben Phenoxyethanol Potassium Sorbate Propylparaben Sorbic Acid 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 lightweight, oil-free lotion for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Absorbs quickly to provide intense hydration throughout the day, leaving skin feeling soft and firm. Diminished the appearance of surface lines and 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 every 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 sunglesses.

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 every 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 sunglesses.

Purpose

Provides SPF 30 sun protection.

Description

A lightweight, oil-free lotion for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Absorbs quickly to provide intense hydration throughout the day, leaving skin feeling soft and firm. Diminished the appearance of surface lines and 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, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cetearyl Alcohol, Dimethicone, Styrene/Acrylates Copolymer, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, PPG-2 Isoceteth-20 Acetate, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter) Extract, Caprylyl Methicone, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abeloschuss Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl Linoleate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Hydrogenated Lecithin, Lecithin, Phospholipids, Phytosphingosine, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 Laurate, Polysorbate 80, Potassium Cetyl Phosphate, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, PEG-8, Carbomer, Xanthan Gum, Sodium Hydroxide, BHT, Disodium EDTA, Dimethiconol, Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Butylphenyl Methylpropional Citral, Citronellol, Eugenol, Geraniol, Hexyl Cinnamai, Hydroxyisohexyl 3-Cyclohexene, Carboxaldehyde Limonene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Red 4 (CI 14700), Yellow 6 (CI 15985).

Dosage & Administration

Apply to skin.

Otc Active Ingredient

Active Ingredients: Octinoxate 7.5%, Oxybenzone 5.0%, Octisalate 5.0%, 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 lightweight, oil-free lotion for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Absorbs quickly to provide intense hydration throughout the day, leaving skin feeling soft and firm. Diminished the appearance of surface lines and 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, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cetearyl Alcohol, Dimethicone, Styrene/Acrylates Copolymer, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, PPG-2 Isoceteth-20 Acetate, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter) Extract, Caprylyl Methicone, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abeloschuss Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl Linoleate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Hydrogenated Lecithin, Lecithin, Phospholipids, Phytosphingosine, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 Laurate, Polysorbate 80, Potassium Cetyl Phosphate, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, PEG-8, Carbomer, Xanthan Gum, Sodium Hydroxide, BHT, Disodium EDTA, Dimethiconol, Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Butylphenyl Methylpropional Citral, Citronellol, Eugenol, Geraniol, Hexyl Cinnamai, Hydroxyisohexyl 3-Cyclohexene, Carboxaldehyde Limonene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Red 4 (CI 14700), Yellow 6 (CI 15985).

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 every 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 sunglesses.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Apply to skin.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate 7.5%, Oxybenzone 5.0%, Octisalate 5.0%, 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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