OTC Medication Information: Dr. C. Tuna Sun Face and Body SPF 50

DR. C. TUNA SUN FACE AND BODY SPF 50- avobenzone, octinoxate, octocrylene and homosalate lotion
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:

Butyl Methoxydibenzoylmethane 2,5%
Ethylhexyl Methoxycinnamate 6,5%
Octocrylene 9%
Homosalate 8%

Purpose

Sunscreen

Use:

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:

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.

Keep out of reach of children.

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

Directions:

For Sunscreen Use

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Limit time in the sun, especially from 10 a.m.-2 p.m., wear long- sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.

Other Information:

Protect this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients:

Water/Aqua, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Glyceryl Stearate, Peg-100 Stearate, Glycerin, Ethylhexyl Palmitate, Ceteareth-20, Styrene/Acrylates Copolymer, Cyclopentasiloxane, Phenoxyethanol, Dimethicone, Adansonia Digitata Seed Oil, Calophyllum Inophyllum Seed Oil, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Ethylhexylglycerin.

Questions or Comments?

info@farmasius.com (833) 432-7627

Monday – Friday (9 a.m – 9 p.m. EST)

Package Labeling:

DR. C. TUNA SUN FACE AND BODY SPF 50 avobenzone, octinoxate, octocrylene, homosalate lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74690-015 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 25 mg in 1 mL OCTINOXATE (OCTINOXATE) OCTINOXATE 65 mg in 1 mL OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 90 mg in 1 mL HOMOSALATE (HOMOSALATE) HOMOSALATE 80 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALKYL (C12-15) BENZOATE CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE GLYCERIN ETHYLHEXYL PALMITATE POLYOXYL 20 CETOSTEARYL ETHER STYRENE CYCLOMETHICONE 5 PHENOXYETHANOL DIMETHICONE ADANSONIA DIGITATA SEED OIL TAMANU OIL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) TROLAMINE .ALPHA.-TOCOPHEROL ACETATE ETHYLHEXYLGLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:74690-015-01 1 BOTTLE in 1 BOX contains a BOTTLE 1 75 mL in 1 BOTTLE This package is contained within the BOX (74690-015-01)

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