DR. C. TUNA SUNSCREEN 50 SPF UVA UVB PROTECTION FACE AND BODY SUN- avobenzone, octinoxate, octocrylene, homosalate lotion

Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun by

Drug Labeling and Warnings

Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun by is a Otc medication manufactured, distributed, or labeled by Farmasi US LLC, TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Butyl Methoxydibenzoylmethane 2,5%

Ethylhexyl Methoxycinnamate 6,5%

Octocrylene 9%

Homosalate 8%

PURPOSE

Sunscreen

Uses

Helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings

on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. For external use only. - Do not useStop 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. 

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: Ask a doctor. Sun Protection Measures:

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 + 1 (786) 238 7338

Monday - Friday (9 a.m - 6 p.m. EST)

SPL UNCLASSIFIED SECTION

Manufactured by: Tan-Alize Kozmetik ve Temizlik Ürünleri San. ve. Tic. A.S. Ömerli Mah. Uran Cad. No: 32 / 34797 Cekmeköy / ISTANBUL 

Made in TURKEY

EU REsponsible Person: Farmasi Central Europe S.R.O. Stará Vajnorská Republika. Distributed By: FARMASI US LLC 2315 NW 107 TH AVE, STE 1B 12, DORAL , FL 33172.

Package Labeling

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
TAMANU OIL (UNII: JT3LVK84A1)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-006-01	75 mL in 1 TUBE; Type 0: Not a Combination Product	01/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/08/2020

Labeler - Farmasi US LLC (113303351)

Establishment
Name	Address	ID/FEI	Business Operations
TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI		365979587	manufacture(74690-006)