DR. C. TUNA SUN 6 SPF TAN AND CARE CARROT- octinoxate oil

Dr. C. Tuna Sun 6 SPF Tan and Care Carrot by

Drug Labeling and Warnings

Dr. C. Tuna Sun 6 SPF Tan and Care Carrot 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

Ethylhexyl Methoxycinnamate 3,5%

PURPOSE

Sunscreen

Uses

Helps prevent sunburn.

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

Apply liberally 15 minutes before sun exposure – reapply: after 80 minutes of swimming or sweating – immediately after towel drying – at least every two hours.

Spending time in the sun with a broad spectrum SPF of 6 or higher and other sun protection measures including: - limit time in the sun, especially from 10 a.m. – 2 p.m. – wear long-sleeve 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

Mineral Oil/Paraffinum Liquidum, Fragrance/Parfum, Soybean Oil/Glycine Soja Oil, Daucus Carota Sativa Root Extract, Beta-Carotene, Tocopherol, Coumarin.

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 SUN 6 SPF TAN AND CARE CARROT 
octinoxate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74690-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SOYBEAN OIL (UNII: 241ATL177A)
CARROT (UNII: L56Z1JK48B)
BETA CAROTENE (UNII: 01YAE03M7J)
TOCOPHEROL (UNII: R0ZB2556P8)
COUMARIN (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74690-002-01	115 mL in 1 BOTTLE, SPRAY; 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(74690-002)