BY PHARMICELL LAB PRESTIGE SUN BLOCK SPF40 PA PLUS PLUS PLUS- octinoxate, octisalate, ensulizole, avobenzone cream

By Pharmicell Lab Prestige Sun Block by

Drug Labeling and Warnings

By Pharmicell Lab Prestige Sun Block by is a Otc medication manufactured, distributed, or labeled by Pharmicell Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

INACTIVE INGREDIENT

Inactive ingredient : WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ARBUTIN, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CETEARYL OLIVATE, GLYCERIN, SORBITAN OLIVATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE, SODIUM HYDROXIDE, DIMETHICONE, PANTHENOL, METHYL METHACRYLATE CROSSPOLYMER, VP/HEXADECENE COPOLYMER, POLYSORBATE 60, POLYACRYLATE-13, PHENOXYETHANOL, SORBITAN STEARATE, POLYISOBUTENE, DISODIUM EDTA, TOCOPHERYL ACETATE, SODIUM BENZOATE, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, PEG-100 STEARATE, POTASSIUM SORBATE, CITRUS AURANTIFOLIA (LIME) FLOWER EXTRACT, ADENOSINE, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, BHT, SORBITAN ISOSTEARATE, POLYSORBATE 20, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PYRUS MALUS (APPLE) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, 1,2-HEXANDIOL, CAPRYLYL GLYCOL, CITRUS AURANTIFOLIA (LIME) OIL, PUNICA GRANATUM FLOWER EXTRACT, PINUS SYLVESTRIS LEAF OIL, PRUNUS AVIUM (SWEET CHERRY) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER EXTRACT, HYDROLYZED EXTENSIN, ALOE BARBADENSIS LEAF JUICE, EUCALYPTUS GLOBULUS LEAF OIL, ZEA MAYS (CORN) KERNEL EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, SQUALANE, PHOSPHOLIPIDS, CI 17200, PHYTOSPHINGOSINE, CERAMIDE 3, TROPOLONE, PHYTOSTEROLS, ETHYLHEXYLGLYCERIN

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 sun block 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

INGREDIENTS AND APPEARANCE

BY PHARMICELL LAB PRESTIGE SUN BLOCK  SPF40 PA PLUS PLUS PLUS
octinoxate, octisalate, ensulizole, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60949-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.75 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60949-030-01	50 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2013

Labeler - Pharmicell Co., Ltd. (687744110)

Registrant - Pharmicell Co., Ltd. (687744110)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmicell Co., Ltd.		687744110	manufacture(60949-030)