Drug labels

RoC Barrier Renew AM Moisturizer SPF 30

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · RoC Skincare · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
020aa79f-4fd6-1ea1-e063-6394a90a4464
ID
5dcf3270-8700-3887-e063-6294a90a3805
Effective time
20261014
Version
5
SPL product data elements

RoC Barrier Renew AM Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE 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

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

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

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

Warnings

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.

Keep out of reach of children
Keep out of reach of children Keep out of reach of children.
Dosage and administration

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.

Storage and handling
Other Information Other information. Protect this product from excessive heat and direct sun. May stain some fabrics.
Inactive ingredient

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.

Questions
Questions or comments? Questions or Comments? Call toll free 1-800-RoC-1964 (1-800-762-1964).
Package label principal display panel
Barrier Renew AM Moisturizer SPF 30 Label
Harmonized identifiers (openFDA)
Application number
M020
Brand name
RoC Barrier Renew AM Moisturizer SPF 30
Generic name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Manufacturer name
RoC Skincare
Product NDC
73496-011
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
AVOBENZONE, OCTOCRYLENE, HOMOSALATE, OCTISALATE
SPL ID
5dcf3270-8700-3887-e063-6294a90a3805
SPL set ID
020aa79f-4fd6-1ea1-e063-6394a90a4464
Package NDC
73496-011-00
Is original packager
true
UNII
G63QQF2NOX, 5A68WGF6WM, V06SV4M95S, 4X49Y0596W
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.