OTC Medication Information: Dr. C. Tuna Resurface Essential Day Cream

DR. C. TUNA RESURFACE ESSENTIAL DAY CREAM- homosalate, octinoxate, octocrylene and avobenzone cream
Farmasi US 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.

Drug Facts:

Active Ingredient:

Homosalate 7%
Ethylhexyl Methoxycinnamate 5%
Octocrylene 5%
Butyl Methoxydibenzoylmethane 2%

Purpose

Sunscreen

Use:

Helps to moisturize and protect the skin from sun damage.

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

skin irritation develops when using this product.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Directions: Use daily, every morning 15 minutes before sun exposure. Take enough amounts with the enclosed spatula on your hands; gently apply on clean face and neck.

Inactive Ingredients:

Water/Aqua, Cetyl Alcohol, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Cichorium Intybus Leaf Extract, Hexylene Glycol, Caprylyl Glycol, Glyceryl Stearate SE, Phenoxyethanol, Cetyl Palmitate, Hexyldecanol, Hexyldecyl Laurate, Sodium Stearoyl Glutamate, Glycerin, Sodium Polyacrylate, Helianthus Annuus Seed Oil, Chlorella Vulgaris Extract, Rosmarinus Officinalis Leaf Extract, Niacinamide, Polymethylsilsesquioxane, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin.

Questions or Comments?

info@farmasius.com (833) 432-7627

Monday – Friday (9 a.m – 9 p.m. EST)

Package Labeling:

Label4
(click image for full-size original)

DR. C. TUNA RESURFACE ESSENTIAL DAY CREAM
homosalate, octinoxate, octocrylene, avobenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74690-016
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 70 mg in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 50 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
DICAPRYLYL CARBONATE
MEDIUM-CHAIN TRIGLYCERIDES
CHICORY LEAF
HEXYLENE GLYCOL
CAPRYLYL GLYCOL
GLYCERYL STEARATE SE
PHENOXYETHANOL
CETYL PALMITATE
HEXYLDECANOL
HEXYLDECYL LAURATE
SODIUM STEAROYL GLUTAMATE
GLYCERIN
SUNFLOWER OIL
CHLORELLA VULGARIS
ROSEMARY
NIACINAMIDE
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
EDETATE DISODIUM ANHYDROUS
XANTHAN GUM
ETHYLHEXYLGLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74690-016-01 1 JAR in 1 BOX contains a JAR
1 50 mL in 1 JAR This package is contained within the BOX (74690-016-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/25/2021
Labeler — Farmasi US LLC (113303351)

Revised: 07/2021 Farmasi US LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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