Otc - Active Ingredient
DRUG FACTS
Active Ingredients
Octocrylene 5%
Octisalate 2%
Tone Control Morning Cream Spf 15 Cream
FDA Label NDC 54111-173
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bentley Laboratories, Llc for the product Tone Control Morning Cream Spf 15 (NDC 54111-173). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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
res
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