TONE CONTROL MORNING CREAM SPF 15- octocrylene and octisalate cream cream 
Bentley Laboratories, LLC

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.

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Tone Control Morning Cream SPF 15

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

Purpose .... Sunscreem

Uses: Helps prevent sunburn.

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 the reach of children. If swallowed get medical help or contact a Poison Control center right away.

Directions• Apply generously 15 minutes before sun exposure. • Use in the morning.
• Reapply every 2 hours. • Use a water resistant sunscreen if swimming or sweating. • Rub
cream gently into your face and neck, avoiding the eyes.

Other information • Protect the product in this container from excessive heat and direct sun.

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

Tone Control Morning Cream SPF 15
SPF 15

Distributed by Geologie
2578 Broadway #A212
New York, NY 10025

20 ml .67 fl oz

20 mL Label

173-20 pkg

173-20 Card

60 mL Label

173-60 pkg

173-60 Card

res

TONE CONTROL MORNING CREAM SPF 15 
octocrylene and octisalate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-173
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54111-173-2020 mL in 1 TUBE; Type 0: Not a Combination Product07/18/2023
2NDC:54111-173-6060 mL in 1 TUBE; Type 0: Not a Combination Product07/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/18/2023
Labeler - Bentley Laboratories, LLC (068351753)
Registrant - Geologie (081158549)

Revised: 7/2023
Document Id: d6421f8d-9022-4d5c-92c9-22389775c935
Set id: b4e3cd1c-ae42-4995-a314-96d24d328e41
Version: 1
Effective Time: 20230722
 
Bentley Laboratories, LLC