roc barrier renew am moisturizer spf 30

roc barrier renew am moisturizer spf 30
SPL v4
SPL
SPL Set ID 020aa79f-4fd6-1ea1-e063-6394a90a4464
Route
topical
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2 g) octocrylene (4 g) homosalate (5.5 g) octisalate (4.5 g)
Inactive Ingredients
shea butter withania somnifera root biosaccharide gum-4 candelilla wax butylene glycol astragalus mongholicus root oleic acid 1,2-hexanediol tocopherol isododecane glycerin polyglyceryl-4 isostearate c12-20 alkyl glucoside ethylhexylglycerin glyceryl monobehenate water c14-22 alcohols green tea leaf peg-7 trimethylolpropane coconut ether phenoxyethanol squalane octyldodecyl neopentanoate sorbitan isostearate .beta.-sitosterol ceramide ng ceramide np

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-01

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 aging caused by the sun

Description

Active ingredients Purpose Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% Sunscreen


Medication Information

Warnings

Warnings

For external use only

Do nut 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 swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early signs of aging caused by the sun

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 aging caused by the sun

Other Information

Other information. Protect this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients

Inactive ingredients Water/Aqua/Eau, Butylene Glycol, Octyldodecyl Neopentanoate, C14-22 Alcohols, Isododecane, Glycerin, Squalane, Sorbitan Isostearate, Beta-Sitosterol, Astragalus Membranaceus Root Extract, Butyrospermum Parkii (Shea) Butter, Oleic Acid, Ceramide NG, Ceramide NP, Withania Somnifera Root Extract, Glyceryl Behenate, Alteromonas Ferment Extract, Polyglyceryl-4 Isostearate, Biosaccharide Gum-4, Camellia Sinensis Leaf Extract, Euphorbia Cerifera (Candelilla) Wax, Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, C12-20 Alkyl Glucoside, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Tocopherol, Ethylhexylglycerin, 1,2-Hexanediol, Phenoxyethanol.

Description

Active ingredients Purpose Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% Sunscreen

Section 51945-4

Active Ingredients

Active ingredients Purpose

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% Sunscreen

Questions Or Comments?

Questions or Comments?

Call toll free 1-800-RoC-1964 (1-800-762-1964).

Directions for Sunscreen Use

Directions For Sunscreen use: Apply generously and evenly 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 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. Children under 6 months of age: Ask a doctor.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Warnings

Warnings

For external use only

Do nut 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 swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early signs of aging caused by the sun

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 aging caused by the sun

Other Information

Other information. Protect this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients

Inactive ingredients Water/Aqua/Eau, Butylene Glycol, Octyldodecyl Neopentanoate, C14-22 Alcohols, Isododecane, Glycerin, Squalane, Sorbitan Isostearate, Beta-Sitosterol, Astragalus Membranaceus Root Extract, Butyrospermum Parkii (Shea) Butter, Oleic Acid, Ceramide NG, Ceramide NP, Withania Somnifera Root Extract, Glyceryl Behenate, Alteromonas Ferment Extract, Polyglyceryl-4 Isostearate, Biosaccharide Gum-4, Camellia Sinensis Leaf Extract, Euphorbia Cerifera (Candelilla) Wax, Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, C12-20 Alkyl Glucoside, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Tocopherol, Ethylhexylglycerin, 1,2-Hexanediol, Phenoxyethanol.

Section 51945-4 (51945-4)

Active Ingredients

Active ingredients Purpose

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% Sunscreen

Questions Or Comments? (Questions or comments?)

Questions or Comments?

Call toll free 1-800-RoC-1964 (1-800-762-1964).

Directions for Sunscreen Use

Directions For Sunscreen use: Apply generously and evenly 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 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. Children under 6 months of age: Ask a doctor.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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