YADAH TWIN ANGEL BB- titanium dioxide, octinoxate, zinc oxide cream
YADAH Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

71026-005 YADAH TWIN ANGEL BB

Titanium Dioxide 9.54%
Octinoxate 4.86%
Zinc Oxide 2.86%

Sunscreen

Helps prevent sunburn

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

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, Pentylene Glycol, Sodium Chloride, Iron Oxides (CI 77492), Disteardimonium Hectorite, Ozokerite, Sorbitan Isostearate, Ricinus Communis (Castor) Seed Oil, Beeswax, Methyl Methacrylate Crosspolymer, Trimethylsiloxysilicate, Iron Oxides (CI 77491), Diisostearyl Malate, Caprylic/Capric Triglyceride, Phenoxyethanol, Aluminum Hydroxide, Iron Oxides (CI 77499), Diglyceryl Sebacate/Isopalmitate, Stearic Acid, Triethoxycaprylylsilane, Ceresin, Mica (CI 77019), Fragrance(Parfum), Dimethiconol, Phytosteryl Isostearyl Dimer Dilinoleate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Microcrystalline Wax, Dimethicone, Glyceryl Ethylhexanoate/Stearate/Adipate, VP/Hexadecene Copolymer, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Dimethicone Crosspolymer, Adenosine, Silica Dimethyl Silylate, Synthetic Wax, Ethylhexylglycerin, Silica Silylate, Hydrogenated Vegetable Oil, Ethylene/Propylene Copolymer, Polyglyceryl-2 Triisostearate, Red 7 (CI 15850:1), Methicone, Red 6 (CI 15850), Polyglyceryl-2 Diisostearate, Caprylyl Glycol, Portulaca Oleracea Extract, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea) Butter, Hydroxyapatite, Polyvinylalcohol Crosspolymer, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Nylon-12 Fluorescent Brightener 230 Salt, Camellia Sinensis Leaf Extract, Cereus Grandiflorus (Cactus) Flower Extract

image description

YADAH TWIN ANGEL BB
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71026-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	95.4 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48.6 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	28.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
NIACINAMIDE (UNII: 25X51I8RD4)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERESIN (UNII: Q1LS2UJO3A)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIGLYCERYL SEBACATE/ISOPALMITATE (UNII: XK79T95N8Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
PHYTOSTERYL ISOSTEARYL DIMER DILINOLEATE (UNII: MRH313IE85)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ADENOSINE (UNII: K72T3FS567)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
METHICONE (20 CST) (UNII: 6777U11MKT)
D&C RED NO. 6 (UNII: 481744AI4O)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PURSLANE (UNII: M6S840WXG5)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
SHEA BUTTER (UNII: K49155WL9Y)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71026-005-02	1 in 1 CARTON	08/02/2017	12/10/2018
1	NDC:71026-005-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/02/2017	12/10/2018

Labeler - YADAH Co., Ltd. (688289967)

Registrant - YADAH Co., Ltd. (688289967)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc		689049693	manufacture(71026-005)

Revised: 12/2018

Document Id: 7cb0f1cd-ba35-13aa-e053-2991aa0a5858

Set id: 8554ce3e-fbd1-426f-bf0c-ad974364f353

Version: 2

Effective Time: 20181210

YADAH Co., Ltd.