Label: BY PHARMICELL LAB PRESTIGE SUN BLOCK SPF40 PA PLUS PLUS PLUS- octinoxate, octisalate, ensulizole, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60949-030-01 - Packager: Pharmicell Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 19, 2013
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- ACTIVE INGREDIENT
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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
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BY PHARMICELL LAB PRESTIGE SUN BLOCK SPF40 PA PLUS PLUS PLUS
octinoxate, octisalate, ensulizole, avobenzone creamProduct 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)
