Bc1145

Bc1145
SPL v1
SPL
SPL Set ID ce3b375e-14fe-46d0-829e-ba850e191a42
Route
TOPICAL
Published
Effective Date 2012-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.68 g) Octisalate (2.45 g) Oxybenzone (1.96 g) Octocrylene (1.47 g) Avobenzone (0.98 g)
Inactive Ingredients
Water Dimethicone Glycerin Petrolatum Butylene Glycol Butyloctyl Salicylate Medium-chain Triglycerides Cetostearyl Alcohol Peg-100 Stearate Shea Butter Hydrogenated Soybean Lecithin Dimethyl Capramide Ceramide 1 Ceramide 3 Ceramide 6 Ii Fucus Serratus Yeast Retinyl Linoleate .alpha.-tocopherol Acetate Polyoxyl 40 Hydrogenated Castor Oil Tramiprosate Phytosphingosine Ammonium Acryloyldimethyltaurate/vp Copolymer Cholesterol Sodium Lauroyl Lactylate Peg-8 Laurate Polysorbate 20 Sodium Dodecylbenzenesulfonate Docosanol Pentylene Glycol High Density Polyethylene Xanthan Gum Edetic Acid Sodium Hydroxide Butylated Hydroxytoluene Edetate Disodium Mica Stannic Oxide Isomethyl-.alpha.-ionone Butylphenyl Methylpropional Hydroxycitronellal Ethylparaben Methylparaben Phenoxyethanol Potassium Sorbate Propylparaben Sodium Benzoate Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-12-22

Description

This rich, replenishing moisture cream with skin identical Ceramide Triple Complex hydrates deeply to restore skin's natural protective barrier and ease the look of fine lines and wrinkles. Nutrient rich sea minerals including calcium help support skin’s natural processes to fortify thin, fragile looking skin. Our patented retinyl complex is clinically proven to optimize surface cell turnover to improve the appearance of age spots, discolorations and overall radiance.

Indications and Usage

Apply to face and throat.

Purpose

Provides SPF 30 Sun Protection.

Dosage and Administration

To Use: Apply to cleansed face and throat. 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 mthis 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 Children under 6 months: Ask a doctor.  


Medication Information

Indications and Usage

Apply to face and throat.

Purpose

Provides SPF 30 Sun Protection.

Dosage and Administration

To Use: Apply to cleansed face and throat.

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 mthis 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

Children under 6 months: Ask a doctor.

 

Description

This rich, replenishing moisture cream with skin identical Ceramide Triple Complex hydrates deeply to restore skin's natural protective barrier and ease the look of fine lines and wrinkles. Nutrient rich sea minerals including calcium help support skin’s natural processes to fortify thin, fragile looking skin. Our patented retinyl complex is clinically proven to optimize surface cell turnover to improve the appearance of age spots, discolorations and overall radiance.

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

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Glycerin, Hydrogenated Polyisobutene, Petrolatum, Glyceryl Stearate, Butylene Glycol, Butyloctly Salicylate, Caprylic/Capric Triglyceride, Cetearyl Alochol, PEG-100 Stearate, Butyrospermum Parkii (Shea Butter), Hydrogenated Lecithin, Dimethylcapramide, Ceramide 1, Ceramide 3, Ceramide 6 II, Fucus Serratus Extract, Yeast Extract/Faex/Extrait de Levure, Retinyl Lonoleate, Tocopheryl Acetate, Cetearyl Dimethicone Crosspolymer, PEG-40 Hydrogenated Castor Oil, Soy Amino Acids, 3-Aminopropane Sulfonic Acid, Calcium Hydroxymethionine, Hydrolyzed Soy Protein, Methyl Methacrylate Crosspolymer, Phytosphingosine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cholesterol, Sodium Lauroyl Lactylate, PEG-8 Laurate, Polysorbate 20, Sodium Dodecylbenzenesulfonate, Styrene/Acrylates Copolymer, Behenyl Alcohol, Pentylene Glycol, Carbomer, Hydroxyethylcellulose, Polyethylene, Xanthan Gum, EDTA, Sodium Hydroxide, BHT, Disodium EDTA, Mica, Tin Oxide, Aminopropyl Dimethicone, Fragrance/Parfum, Alpha-Isomethyl Ionone, Butylpheyl Methylpropional, Citronellol, Hydroxycitronellal, Ethylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Benzoate, Titanium Dioxide (CI 77891).

Otc Active Ingredient

Active Ingredients: Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 3.0%, 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 right away.


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)

This rich, replenishing moisture cream with skin identical Ceramide Triple Complex hydrates deeply to restore skin's natural protective barrier and ease the look of fine lines and wrinkles. Nutrient rich sea minerals including calcium help support skin’s natural processes to fortify thin, fragile looking skin. Our patented retinyl complex is clinically proven to optimize surface cell turnover to improve the appearance of age spots, discolorations and overall radiance.

Otc Purpose (OTC - PURPOSE)

Provides SPF 30 Sun Protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Glycerin, Hydrogenated Polyisobutene, Petrolatum, Glyceryl Stearate, Butylene Glycol, Butyloctly Salicylate, Caprylic/Capric Triglyceride, Cetearyl Alochol, PEG-100 Stearate, Butyrospermum Parkii (Shea Butter), Hydrogenated Lecithin, Dimethylcapramide, Ceramide 1, Ceramide 3, Ceramide 6 II, Fucus Serratus Extract, Yeast Extract/Faex/Extrait de Levure, Retinyl Lonoleate, Tocopheryl Acetate, Cetearyl Dimethicone Crosspolymer, PEG-40 Hydrogenated Castor Oil, Soy Amino Acids, 3-Aminopropane Sulfonic Acid, Calcium Hydroxymethionine, Hydrolyzed Soy Protein, Methyl Methacrylate Crosspolymer, Phytosphingosine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cholesterol, Sodium Lauroyl Lactylate, PEG-8 Laurate, Polysorbate 20, Sodium Dodecylbenzenesulfonate, Styrene/Acrylates Copolymer, Behenyl Alcohol, Pentylene Glycol, Carbomer, Hydroxyethylcellulose, Polyethylene, Xanthan Gum, EDTA, Sodium Hydroxide, BHT, Disodium EDTA, Mica, Tin Oxide, Aminopropyl Dimethicone, Fragrance/Parfum, Alpha-Isomethyl Ionone, Butylpheyl Methylpropional, Citronellol, Hydroxycitronellal, Ethylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Benzoate, Titanium Dioxide (CI 77891).

Indications and Usage (INDICATIONS AND USAGE)

Apply to face and throat.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%, Octocrylene 3.0%, Avobenzone 2.0%.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

To Use: Apply to cleansed face and throat.

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 mthis 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

Children under 6 months: Ask a doctor.

 

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 right away.


Advanced Ingredient Data


Raw Label Data

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