Label: ROC BARRIER RENEW AM MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 73496-011-00
- Packager: RoC Skincare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- Active Ingredients
- Uses
- Indications and Usage
- Warnings
- Keep out of reach of children
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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
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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.
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INGREDIENTS AND APPEARANCE
ROC BARRIER RENEW AM MOISTURIZER SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct 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)
