Label: BY PHARMICELL LAB PRESTIGE BB SPF30 PA PLUS PLUS- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60949-040-01 - Packager: Pharmicell Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 7, 2013
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- ACTIVE INGREDIENT
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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
- WARNINGS
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- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BY PHARMICELL LAB PRESTIGE BB SPF30 PA PLUS PLUS
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60949-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.22 g in 50 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.72 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60949-040-01 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(60949-040)