Moisturizing Renewal Cream Broad Spectrum Spf 30 Us

Moisturizing Renewal Cream Broad Spectrum Spf 30 Us
SPL v4
SPL
SPL Set ID 2e69011b-5cc8-4df4-b4d8-0948d0b4a33d
Route
TOPICAL
Published
Effective Date 2022-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (26 mg)
Inactive Ingredients
Water Caprylyl Trisiloxane Dipropylene Glycol Dicaprylyl Carbonate Peg/ppg-17/6 Copolymer Glyceryl Monostearate Peg-100 Stearate Potassium Cetyl Phosphate Thermus Thermophilus Lysate Methyl Glucose Sesquistearate Tetrahexyldecyl Ascorbate Allantoin Carnosine .alpha.-tocopherol Acetate Tocopherol Hyaluronate Sodium Soybean Oil Sodium Oleate Hydrogenated Palm Glycerides Panthenol Glycerin Adenosine Chondrus Crispus Carrageenan Hexylene Glycol Silibinin Sorbitan Isostearate Caprylyl Glycol Cetyl Alcohol Sodium Laureth-12 Sulfate Disodium Lauryl Sulfosuccinate Gluconolactone Polysorbate 60 Phenoxyethanol Edetate Disodium Anhydrous Potassium Sorbate Potassium Hydroxide Sodium Benzoate .alpha.-hexylcinnamaldehyde Hydroxycitronellal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.6%

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.

Warnings

For external use only.

Directions

• Apply liberally and evenly 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: Ask a doctor • 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 value 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-sleeved shirts, pants, hats, and sunglasses











Sun Protection Measures.

Do Not Use

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.6%

Inactive Ingredients:

Aqua (Water, Eau), Caprylyl Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Glyceryl Stearate, Peg-100 Stearate, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, Methyl Glucose Sesquistearate, Oligopeptide-41, Oligopeptide-24, Tetrahexyldecyl Ascorbate, Allantoin, Carnosine, Tocopheryl Acetate, Tocopherol, Sodium Hyaluronate, Glycine Soja (Soybean) Oil, Sodium Oleate, Hydrogenated Lecithin, Hydrogenated Palm Glycerides, Panthenol, Lecithin, Glycerin, Adenosine, Chondrus Crispus Extract, Hexylene Glycol, Silybin, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Caprylyl Glycol, Polyacrylate-15, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Parfum (Fragrance), PEG-10 Dimethicone, C11-15 Alketh-7, C11-15 Alketh-40, Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Gluconolactone, Polyacrylate-17, Polysorbate 60, Phenoxyethanol, Disodium EDTA, Potassium Sorbate, Potassium Hydroxide, Sodium Benzoate, Hexyl Cinnamal, Hydroxycitronellal.

Questions Or Comments?

Call , M – F 8am – 5pm CST. 1-866-986-7083

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.


Structured Label Content

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.

Purpose

Sunscreen

Warnings

For external use only.

Directions

• Apply liberally and evenly 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: Ask a doctor • 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 value 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-sleeved shirts, pants, hats, and sunglasses











Sun Protection Measures.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.6%

Inactive Ingredients: (Inactive ingredients:)

Aqua (Water, Eau), Caprylyl Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Glyceryl Stearate, Peg-100 Stearate, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, Methyl Glucose Sesquistearate, Oligopeptide-41, Oligopeptide-24, Tetrahexyldecyl Ascorbate, Allantoin, Carnosine, Tocopheryl Acetate, Tocopherol, Sodium Hyaluronate, Glycine Soja (Soybean) Oil, Sodium Oleate, Hydrogenated Lecithin, Hydrogenated Palm Glycerides, Panthenol, Lecithin, Glycerin, Adenosine, Chondrus Crispus Extract, Hexylene Glycol, Silybin, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Caprylyl Glycol, Polyacrylate-15, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Parfum (Fragrance), PEG-10 Dimethicone, C11-15 Alketh-7, C11-15 Alketh-40, Sodium Laureth-12 Sulfate, Disodium Lauryl Sulfosuccinate, Gluconolactone, Polyacrylate-17, Polysorbate 60, Phenoxyethanol, Disodium EDTA, Potassium Sorbate, Potassium Hydroxide, Sodium Benzoate, Hexyl Cinnamal, Hydroxycitronellal.

Questions Or Comments? (Questions or comments?)

Call , M – F 8am – 5pm CST. 1-866-986-7083

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

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.


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Raw Label Data

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