Prevage Anti-aging Moisture Lotion Spf 30

Prevage Anti-aging Moisture Lotion Spf 30
SPL v3
SPL
SPL Set ID b2bff796-1579-2686-e053-2995a90ad6c7
Route
TOPICAL
Published
Effective Date 2020-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octocrylene (2.2 mg) Octisalate (5 mg) Avobenzone (2 mg) Oxybenzone
Inactive Ingredients
Mica Titanium Dioxide Cetostearyl Alcohol Propylene Glycol Alkyl (c12-15) Benzoate Carbomer 1342 Dimethicone 1000 Water Glycerin Butylated Hydroxytoluene Chlorphenesin Methylparaben Ferric Oxide Red Sodium Pyrrolidone Carboxylate Ferric Oxide Yellow Shea Butter Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate Hyaluronate Sodium Trehalose Hydrogenated Palm Glycerides Polyoxyl 40 Hydrogenated Castor Oil Polyquaternium-51 (2-methacryloyloxyethyl Phosphorylcholine/n-butyl Methacrylate; 4:1) Linalool, (+/-)- Phenoxyethanol Fd&c Red No. 4 Fd&c Yellow No. 5 Potassium Cetyl Phosphate Acrylic Acid Glyceryl Stearate Se Sodium Hydroxide Cyclomethicone 5 Cyclomethicone 6 Ergothioneine Urea Isomethyl-.alpha.-ionone 2-(4-(diethylamino)-2-hydroxybenzoyl)benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-02

Description

OCTINOXATE, 7.5 % OCTISALATE, 5.0 % OXYBENZONE, 5.0 % OCTOCRYLENE, 2.2 % AVOBENZONE, 2.0 %

Purpose

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.


Medication Information

Indications and Usage
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
Purpose

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.

Description

OCTINOXATE, 7.5 % OCTISALATE, 5.0 % OXYBENZONE, 5.0 % OCTOCRYLENE, 2.2 % AVOBENZONE, 2.0 %

Section 50565-1

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

Section 51945-4

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 using and ask a docotr is rash occurs.

Active Ingredients

OCTINOXATE, 7.5 %

OCTISALATE, 5.0 %

OXYBENZONE, 5.0 %

OCTOCRYLENE, 2.2 %

AVOBENZONE, 2.0 %

Inactive Ingredients

WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, POTASSIUM CETYL PHOSPHATE, GLYCERYL POLYACRYLATE, GLYCERYL STEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARBOMER, CYCLOHEXASILOXANE, CYCLOPENTASILOXANE, ERGOTHIONEINE, HYDROGENATED PALM GLYCERIDES, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, MICA, PARFUM/FRAGRANCE, POLYQUATERNIUM-51, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, TREHALOSE, UREA, BHT, ALPHA-ISOMETHYL IONONE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, IRON OXIDES, YELLOW (CI 77492), RED 4 (CI 14700), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140).

Directions for Sunscreen Use:

Apply liberally 15 minutes before sun exposure

Replly:

- 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 od skin cancer and warly 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

Indications and Usage (34067-9)
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose

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.

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 using and ask a docotr is rash occurs.

Active Ingredients (ACTIVE INGREDIENTS)

OCTINOXATE, 7.5 %

OCTISALATE, 5.0 %

OXYBENZONE, 5.0 %

OCTOCRYLENE, 2.2 %

AVOBENZONE, 2.0 %

Inactive Ingredients

WATER/AQUA/EAU, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, POTASSIUM CETYL PHOSPHATE, GLYCERYL POLYACRYLATE, GLYCERYL STEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARBOMER, CYCLOHEXASILOXANE, CYCLOPENTASILOXANE, ERGOTHIONEINE, HYDROGENATED PALM GLYCERIDES, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, MICA, PARFUM/FRAGRANCE, POLYQUATERNIUM-51, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, TREHALOSE, UREA, BHT, ALPHA-ISOMETHYL IONONE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, IRON OXIDES, YELLOW (CI 77492), RED 4 (CI 14700), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140).

Directions for Sunscreen Use: (Directions For Sunscreen Use:)

Apply liberally 15 minutes before sun exposure

Replly:

- 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 od skin cancer and warly 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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