Always Triple BB by Elishacoy Co., Inc. / Cosmecca Korea Co., Ltd. 69013-001_Deactivation

Always Triple BB by

Drug Labeling and Warnings

Always Triple BB by is a Otc medication manufactured, distributed, or labeled by Elishacoy Co., Inc., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALWAYS TRIPLE BB- titanium dioxide, zinc oxide cream 
Elishacoy Co., Inc.

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.

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69013-001_Deactivation

Titanium Dioxide (10.4%), Zinc Oxide (1.44%)

Whitening

Anti-Wrinkle

SPF30 PA++

Chemical Action Free

Keep out of reach of children.

ElishaCoy

Noblesse Naturalism

Always Triple BB

This multifunctional product protects skin from the sun, improves wrinkles and whitens skin. It can be used as makeup base or foundation. Not only the product naturally tones skin but it also conceals any imperfections. Natural ingredients like royal jelly and caviar help to protect and improve skin.

+ Broad-Spectrum UV filters (SPF30, PA++) protects against both UVA and UVB rays. W/S formula is water/perspiration-resistant and supplies essential moisture and nutrients to skin.

+ Contains skin-soothing botanicals (Portulaca oleracea L. and Morus alba Linne) for sensitive skin.

[Effects] Skin whitening, Wrinkle improvements

UVA/B Protection [SPF30, PA++]

Warnings

[Directions] Apply liberally to all exposed skin at the end of your skin care routine and then gently pat to enhance absorption.

Water, Phenyl Trimethicone, Dimethicone, Cyclomethicone, Propylene Glycol Dicaprylata/Dicaprate, Butylene Glycol, Cyclopentasiloxane, Propylene Glycol, Silica, Bis-PEG/PPG-14/14 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Arbutin, Sodium Chloride, Sorbitan Sesquioleate, Triethoxycaprylylsilane, Disteardimonium Hectorite, Talc, Glycerin, Caviar Extract, Royal Jelly Extract, Malpighia Punicifolia (Acerola) Fruit Extract, Ozokerite, Rosa Canina Fruit Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Methylparaben, Chlorphenesin, Hexyl Laurate, Butylparaben, Propylparaben, Tocopheryl Acetate, Dimethicone/Methicone Copolymer, Adenosine, Disodium EDTA, BHT, Sodium Hyaluronate, Iron Oxides

ALWAYS TRIPLE BB 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69013-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ARBUTIN (UNII: C5INA23HXF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)
ROYAL JELLY (UNII: L497I37F0C)
MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)
CERESIN (UNII: Q1LS2UJO3A)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69013-001-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2014	11/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/27/2014	11/19/2019

Labeler - Elishacoy Co., Inc. (631138567)

Establishment
Name	Address	ID/FEI	Business Operations
Elishacoy Co., Ltd.		631138567	manufacture(69013-001)

Revised: 11/2019

Document Id: 98361488-f50a-8106-e053-2a95a90a8d94

34390-5

Set id: e71f65b8-bb12-4075-bd4e-28200b8f66fd

Version: 4

Effective Time: 20191125

 

Elishacoy Co., Inc.