Label: MOISTURIZING MORNING CREAM SPF 15- octocrylene and octisalate cream cream
- NDC Code(s): 54111-172-20, 54111-172-60
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings •Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of
skin cancer and early skin aging. This product has been shown to only help prevent sunburn,
not skin cancer or early skin aging. • For external use only. • Do not 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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Caprylic/Cap-
ric Triglyceride, Niacinamide, Cetearyl Olivate, Cetyl Alcohol, Water (Aqua/Eau), Sorbitan Olivate,
Sodium Hyaluronate, Silica, Argania Spinosa Kernel Oil, Glycerin, Glyceryl Stearate,
Polyglyceryl-10 Laurate, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Polyacrylate
Crosspolymer-6, Sodium Stearoyl Glutamate, Ethyl Ferulate, Ethylhexylglycerin, Ricinus Com-
munis (Castor) Seed Oil, Cocos Nucifera (Coconut) Oil, Opuntia Ficus-Indica Seed Oil, Vitis Vini-
fera (Grape) Seed Oil - Product Labeling
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INGREDIENTS AND APPEARANCE
MOISTURIZING MORNING CREAM SPF 15
octocrylene and octisalate cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-172 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.0 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) NIACINAMIDE (UNII: 25X51I8RD4) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) SORBITAN OLIVATE (UNII: MDL271E3GR) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ARGAN OIL (UNII: 4V59G5UW9X) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ETHYL FERULATE (UNII: 5B8915UELW) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CASTOR OIL (UNII: D5340Y2I9G) COCONUT OIL (UNII: Q9L0O73W7L) OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J) GRAPE SEED OIL (UNII: 930MLC8XGG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-172-20 20 mL in 1 TUBE; Type 0: Not a Combination Product 07/18/2023 2 NDC:54111-172-60 60 mL in 1 TUBE; Type 0: Not a Combination Product 07/18/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/18/2023 Labeler - Bentley Laboratories, LLC (068351753) Registrant - Geologie (081158549)
