SUN PROJECT WATER SUN CREAM SPF50- octinoxate, homosalate, octisalate, octocrylene, titanium dioxide cream

Sun Project Water Sun Cream SPF50 by

Drug Labeling and Warnings

Sun Project Water Sun Cream SPF50 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

Ethylhexyl Methoxycinnamate 6.80%
Homosalate 6.00%
Ethylhexyl Salicylate 4.50%
Octocrylene 2.50%
Titanium Dioxide 1.40%

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, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclomethicone, Alcohol, Glyceryl Stearate, 1,2-Hexanediol, Behenyl Alcohol, Methyl Methacrylate Crosspolymer, Peg-100 Stearate, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Phenoxyethanol, Aluminum Stearate, Polyhydroxystearic Acid, Octyldodecanol, Fragrance, Bambusa Vulgaris Water, Xanthan Gum, Alumina, Echium Plantagineum Seed Oil, Glycine Soja (Soybean) Lipids, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Plukenetia Volubilis Seed Oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN PROJECT WATER SUN CREAM SPF50 
octinoxate, homosalate, octisalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70618-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.4 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.25 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.7 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALCOHOL (UNII: 3K9958V90M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-100 STEARATE (UNII: YD01N1999R)
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PURSLANE (UNII: M6S840WXG5)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
OCTYLDODECANOL (UNII: 461N1O614Y)
BAMBUSA VULGARIS WHOLE (UNII: WCD45M1BSK)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70618-006-02	1 in 1 CARTON	04/08/2016
1	NDC: 70618-006-01	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
OTC monograph not final	part352	04/08/2016

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(70618-006)