BE BEAUTIFUL LUMINOUS CC CREAM- octinoxate, titanium dioxide, octisalate cream

Be Beautiful Luminous CC Cream by

Drug Labeling and Warnings

Be Beautiful Luminous CC Cream 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]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate 6.00%
Titanium Dioxide 4.72%
Ethylhexyl Salicylate 3.00

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, Glycerin, Butylene Glycol, Alcohol Denat., Isoamyl P-Methoxycinnamate, Cyclopentasiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Niacinamide, Glyceryl Stearate, Synthetic Fluorphlogopite, Mica, Polysorbate 60, Triethoxycaprylylsilane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Peg-100 Stearate, Portulaca Oleracea Extract, Coco-Caprylate/Caprate, Silica, Phenoxyethanol, Fragrance, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides(Ci 77492), Tocopheryl Acetate, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Iron Oxides(Ci 77491), Adenosine, Polyurethane-11, Disodium Edta, Tin Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BE BEAUTIFUL LUMINOUS CC CREAM 
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70618-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.4 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.89 g  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.2 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
AMILOXATE (UNII: 376KTP06K8)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICA (UNII: V8A1AW0880)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
PURSLANE (UNII: M6S840WXG5)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DOCOSANOL (UNII: 9G1OE216XY)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70618-001-02	1 in 1 CARTON	04/08/2016
1	NDC: 70618-001-01	40 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	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(70618-001)