ROC BARRIER RENEW AM MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

RoC Barrier Renew AM Moisturizer SPF 30 by

Drug Labeling and Warnings

RoC Barrier Renew AM Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by RoC Skincare, Dermaceutical Laboratories Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active ingredients Purpose

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

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.

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.

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.

Questions or comments?

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROC BARRIER RENEW AM MOISTURIZER SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ASTRAGALUS MONGHOLICUS ROOT (UNII: 922OP8YUPF)
OLEIC ACID (UNII: 2UMI9U37CP)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TOCOPHEROL (UNII: R0ZB2556P8)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
WATER (UNII: 059QF0KO0R)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SQUALANE (UNII: GW89575KF9)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CERAMIDE NG (UNII: C04977SRJ5)
CERAMIDE NP (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-011-00	74 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2023

Labeler - RoC Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaceutical Laboratories Limited Liability Company		078457159	manufacture(73496-011)