Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen Spf 15

Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen Spf 15
SPL v4
SPL
SPL Set ID b3ad9686-47ed-4b60-e053-2995a90abcdd
Route
TOPICAL
Published
Effective Date 2015-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3 mg) Octinoxate (4 mg)
Inactive Ingredients
Tocopherol Trehalose Trifolium Pratense Flower Butylated Hydroxytoluene Benzoic Acid Methylparaben Potassium Sorbate Ferric Oxide Yellow Caprylyl Glycol Edetate Disodium Anhydrous Fructose Ferrosoferric Oxide Alanine Alpinia Zerumbet Leaf Abelmoschus Moschatus Seed Cholesterol Anhydrous Dextrose Acetyl Octapeptide-3 Mannitol Aspartic Acid Butylene Glycol Ceramide 1 Propylparaben Hexylene Glycol Lecithin, Soybean Sodium Lauroyl Lactylate Sucrose Water Isohexadecane Sorbitan Isostearate Ascorbyl Palmitate Carbomer Homopolymer, Unspecified Type Ceramide 3 Ceramide 6 Ii Phenoxyethanol Urea Xanthan Gum Chlorphenesin Hyaluronate Sodium Cyclomethicone 5 Glycerin Mica Aluminum Oxide Dimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Vitamin A Palmitate Phytosphingosine Polyquaternium-51 (2-methacryloyloxyethyl Phosphorylcholine/n-butyl Methacrylate; 3:7) Sodium Chloride Sorbitol Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-11

Description

OCTINOXATE 4.0%.............. Sunscreen TITANIUM DIOXIDE 3.0% .... Sunscreen

Purpose

OCTINOXATE 4.0%.............. Sunscreen TITANIUM DIOXIDE 3.0% .... Sunscreen


Medication Information

Indications and Usage

Helps prevent sunburn

Purpose

OCTINOXATE 4.0%.............. Sunscreen TITANIUM DIOXIDE 3.0% .... Sunscreen

Dosage and Administration

As needed

Description

OCTINOXATE 4.0%.............. Sunscreen TITANIUM DIOXIDE 3.0% .... Sunscreen

Uses

Uses

- Helps prevent sunburn

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 50565-1

Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

Section 55105-1

Sunscreen

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.

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Carton Art

Inactive Ingredients

Inactive Ingredients

WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE, PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Active Ingredients Purpose

OCTINOXATE 4.0%.............. Sunscreen

TITANIUM DIOXIDE 3.0% .... Sunscreen

Directions for Sunscreen Use

Directions For Sunscreen Use:

- Apply liberally 15 minutes before sun exposure

- Reapply:

- at least every 2 hours

- use a water resistant sunscreen if swimming or sweating

- 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

- Children under 6 months: Ask a doctor.


Structured Label Content

Uses

Uses

- Helps prevent sunburn

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

As needed

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)

Sunscreen

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.

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Carton Art (carton art)

Inactive Ingredients

Inactive Ingredients

WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL, DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE, PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Active Ingredients Purpose

OCTINOXATE 4.0%.............. Sunscreen

TITANIUM DIOXIDE 3.0% .... Sunscreen

Directions for Sunscreen Use (Directions For Sunscreen Use)

Directions For Sunscreen Use:

- Apply liberally 15 minutes before sun exposure

- Reapply:

- at least every 2 hours

- use a water resistant sunscreen if swimming or sweating

- 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

- Children under 6 months: Ask a doctor.


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