70618-010_SUN PROJECT SKIN-RELIEF SUN CREAM

SUN PROJECT SKIN-RELIEF SUNCREAM by

Drug Labeling and Warnings

SUN PROJECT SKIN-RELIEF SUNCREAM by is a Otc medication manufactured, distributed, or labeled by THANK YOU FARMER CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUN PROJECT SKIN-RELIEF SUNCREAM- diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol, diethylhexyl butamido triazone cream 
THANK YOU FARMER CO., LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

70618-010_SUN PROJECT SKIN-RELIEF SUN CREAM

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 3%
ETHYLHEXYL TRIAZONE 2.4%
METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL 2%
DIETHYLHEXYL BUTAMIDO TRIAZONE 1.2%

Sunscreen

Helps prevent sunburn

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

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

WATER, DIBUTYL ADIPATE, PROPANEDIOL, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, COCO-CAPRYLATE/CAPRATE, CAPRYLYL METHICONE, GLYCERIN, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, BEHENYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, DECYL GLUCOSIDE, TROMETHAMINE, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, ETHYLHEXYLGLYCERIN, ADENOSINE, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, T-BUTYL ALCOHOL, TOCOPHEROL, SALVIA HISPANICA SEED EXTRACT, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, ANASTATICA HIEROCHUNTICA EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, GARDENIA JASMINOIDES FRUIT EXTRACT, FORSYTHIA SUSPENSA FRUIT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, COPTIS JAPONICA ROOT EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT

SUN PROJECT SKIN-RELIEF SUNCREAM 
diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol, diethylhexyl butamido triazone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70618-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	1.5 mg  in 50 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	1.2 mg  in 50 mL
BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS)	BISOCTRIZOLE	1 mg  in 50 mL
ISCOTRIZINOL (UNII: 2UTZ0QC864) (ISCOTRIZINOL - UNII:2UTZ0QC864)	ISCOTRIZINOL	0.6 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
PROPANEDIOL (UNII: 5965N8W85T)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
NIACINAMIDE (UNII: 25X51I8RD4)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
TROMETHAMINE (UNII: 023C2WHX2V)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
XANTHAN GUM (UNII: TTV12P4NEE)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
TOCOPHEROL (UNII: R0ZB2556P8)
CHIA SEED (UNII: NU0OLX06F8)
EGGPLANT (UNII: W5K7RAS4VK)
ANASTATICA HIEROCHUNTICA WHOLE (UNII: SU125S6473)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
COPTIS JAPONICA ROOT (UNII: JH0SWT16D1)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70618-010-02	1 in 1 CARTON	05/30/2022	02/21/2024
1	NDC: 70618-010-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/30/2022	02/21/2024

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(70618-010)

Revised: 3/2024

Document Id: 149a3926-af6a-6530-e063-6294a90a76f0

34390-5

Set id: 78802cd7-f3c1-4b3c-92ca-ad93e7f788a4

Version: 3

Effective Time: 20240326