BY PHARMICELL LAB PRESTIGE BB SPF30 PA PLUS PLUS- titanium dioxide, zinc oxide cream 
Pharmicell 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.

----------

ACTIVE INGREDIENT

Active ingredient : TITANIUM DIOXIDE 10.44%, ZINC OXIDE 1.44%

INACTIVE INGREDIENT

Inactive ingredient : WATER, CYCLOPENTASILOXANE, DIMETHICONE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, SILICA, CYCLOHEXASILOXANE, GLYCERIN, ORBIGNYA OLEIFERA SEED OIL, METHYL HYDROGENATED ROSINATE, CAPRYLYL METHICONE, ARBUTIN, MAGNESIUM SULFATE, LECITHIN, TALC, POLYGLYCERYL-4 ISOSTEARATE, IRON OXIDES (CI 77492), DISTEARDIMONIUM HECTORITE, HEXYL LAURATE, BEESWAX, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, OZOKERITE, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, PROPYLENE CARBONATE, PROPYLENE GLYCOL STEARATE, SORBITAN LAURATE, SORBITAN OLIVATE, SORBITAN ISOSTEARATE, POLYSORBATE 20, CITRUS AURANTIUM DULCIS (ORANGE) OIL, PROPYLENE GLYCOL LAURATE, HYDROGEN DIMETHICONE, 1,2-HEXANEDIOL, ADENOSINE, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, DISODIUM EDTA, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, POLYGLUTAMIC ACID, GERANIUM MACULATUM OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, SANTALUM ALBUM (SANDALWOOD) OIL, TOURMALINE, ROSE FLOWER OIL, PEARL POWDER, CORAL POWDER, AMETHYST POWDER, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, REHMANNIA GLUTINOSA ROOT EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, OPHIOPOGON JAPONICUS ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, PSIDIUM GUAJAVA FRUIT EXTRACT, BLETILLA STRIATA ROOT EXTRACT, SQUALANE, PHOSPHOLIPIDS, PHYTOSPHINGOSINE, CERAMIDE 3, TROPOLONE, STYRAX BENZOIN GUM, PHYTOSTEROLS, COMMIPHORA MYRRHA OIL, ZEA MAYS (CORN) KERNEL EXTRACT

PURPOSE

Purpose : Sunscreen

WARNINGS

Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and babies.

INDICATIONS AND USAGE

Indications and usage : At the last step of basic skin care, take a proper amount of the BB Cream and spread it evenly over the skin.

DOSAGE AND ADMINISTRATION

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BY PHARMICELL LAB PRESTIGE BB  SPF30 PA PLUS PLUS
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.22 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.72 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60949-040-0150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2013
Labeler - Pharmicell Co., Ltd. (687744110)
Registrant - Pharmicell Co., Ltd. (687744110)
Establishment
NameAddressID/FEIBusiness Operations
Pharmicell Co., Ltd.687744110manufacture(60949-040)

Revised: 7/2013
Document Id: 1b6cb178-e94e-4b6c-b497-dc8c9f5ddbf6
Set id: 813ec937-cbc5-48cd-bca9-ab19b331c0a5
Version: 1
Effective Time: 20130707
 
Pharmicell Co., Ltd.