Otc - Active Ingredient
DRUG FACTS
Active Ingredients
Zinc Oxide 9.4%
Octocrylene 5%
Octisalate 2%
Performance Face Sunscreen Broad Spectrum Cream
FDA Label NDC 54111-188
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 Performance Face Sunscreen Broad Spectrum (NDC 54111-188). 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, inactive ingredient, geologie performance face sunscreen broad spectrum spf 30, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Zinc Oxide ......... Sunscreen
Octocrylene ....... Sunscreen
Octisalate .......... Sunscreen
Indications & Usage
Uses •Helps prevent sunburn • if used as directed with other sun protection measures (see Directions) decreases the
risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings • 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 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
• Rub evenly into your rntire face and neck. • Apply generously liberally 15 minutes before sun exposure.
• Reapply after 40 minutes of swimming or sweating and immediately after towel drying. • Reapply at least every 2 hours
Inactive Ingredient
Inactive Ingredients Water, Butyloctyl Salicylate, Neopentyl Glycol Diheptanoate, Undecane, Glyceryl
Stearate, Glycerin, Cetearyl Alcohol, Poly C10-30 Alkyl Acrylate, Isododecane, Tridecane, Niacinamide, Sodium Hy-
aluronate, Phenoxyethanol, Coco-Caprylate/Caprate, Ceteareth-20, Triceteareth-4 Phosphate, Bisabolol, Caprylyl
Glycol, Xanthan Gum, Triethoxycaprylylsilane, Citric Acid, Ethylhexylglycerin, Polyglyceryl-3 Pentaricinoleate,
Isostearic Acid
Geologie Performance Face Sunscreen Broad Spectrum Spf 30
PERSONALIZED SKINCARE
Performance Face
Sunscreen
Broad Spectrum SPF30
Geologie
Geologie.com
Made in USA of
Imported Materials
Distributed by Geologie
New York, NY 10025
30 mL Tube
75 mL Tube
res
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