TONE CONTROL MORNING CREAM SPF 15- octocrylene and octisalate cream cream

Tone Control Morning Cream SPF 15 by

Drug Labeling and Warnings

Tone Control Morning Cream SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC, Geologie. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredients

Octocrylene 5%

Octisalate 2%

PURPOSE

Purpose .... Sunscreem

INDICATIONS & USAGE

Uses: Helps prevent sunburn.

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

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

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

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

60 mL Label

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INGREDIENTS AND APPEARANCE

TONE CONTROL MORNING CREAM SPF 15 
octocrylene and octisalate cream cream

Product 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)