Label: TONE CONTROL MORNING CREAM SPF 15- octocrylene and octisalate cream cream
- NDC Code(s): 54111-173-20, 54111-173-60
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
INACTIVE INGREDIENT
Inactive Ingredients Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear-
yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina-
mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl
Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower
Extract - Product Labeling
-
INGREDIENTS AND APPEARANCE
TONE CONTROL MORNING CREAM SPF 15
octocrylene and octisalate cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-173 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) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAFFEINE (UNII: 3G6A5W338E) PHENOXYETHANOL (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) ETHYL FERULATE (UNII: 5B8915UELW) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-173-20 20 mL in 1 TUBE; Type 0: Not a Combination Product 07/18/2023 2 NDC:54111-173-60 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 final part352 07/18/2023 Labeler - Bentley Laboratories, LLC (068351753) Registrant - Geologie (081158549)
