THANK YOU FARMER SAFE SUN FLUID AGE 0880- titanium dioxide cream

THANK YOU FARMER Safe Sun Fluid Age 0880 by

Drug Labeling and Warnings

THANK YOU FARMER Safe Sun Fluid Age 0880 by is a Otc medication manufactured, distributed, or labeled by THANK YOU FARMER CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 7.99% ..………………..……Sunscreen

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

WARNINGS

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

WATER, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, NIACINAMIDE, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, 1,2-HEXANEDIOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, CETYL ETHYLHEXANOATE, SILICA, PENTYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, PROPANEDIOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE, POLYACRYLATE CROSSPOLYMER-6, SACCHARIDE HYDROLYSATE, SODIUM STEAROYL GLUTAMATE, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, OCTYLDODECANOL, STEARIC ACID, ETHYLHEXYLGLYCERIN, ADENOSINE, SALVIA HISPANICA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, T-BUTYL ALCOHOL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, GLYCERIN, TOCOPHEROL, CAMELLIA JAPONICA FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT, PANCRATIUM MARITIMUM EXTRACT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THANK YOU FARMER SAFE SUN FLUID AGE 0880 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70618-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.99 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALUMINUM OXIDE (UNII: LMI26O6933)
PROPANEDIOL (UNII: 5965N8W85T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
INVERT SUGAR (UNII: ED959S6ACY)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70618-009-02	1 in 1 CARTON	02/10/2020
1	NDC: 70618-009-01	100 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/10/2020

Labeler - THANK YOU FARMER CO., LTD. (689605142)

Registrant - THANK YOU FARMER CO., LTD. (689605142)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(70618-009)