Label: GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.1- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-044-01 - Packager: SKINFOOD CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 17, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Glycerin, Dicaprylyl Carbonate, Dimethicone, Caprylyl Methicone, Iron Oxides (CI 77492), Magnesium Sulfate, Mica (CI 77019), Disteardimonium Hectorite, Sorbitan Sesquioleate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Euterpe Oleracea Fruit Extract, Ozokerite, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Iron Oxides (CI 77491), Stearic Acid, Methylparaben, Beeswax, Chlorphenesin, Triethoxycaprylylsilane, Fragrance(Parfum), Iron Oxides (CI 77499), Propylparaben, Disodium EDTA, Adenosine, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Melissa Officinalis Leaf Extract, Aspalathus Linearis Extract, Thymus Vulgaris (Thyme) Extract, Jasminum Officinale (Jasmine) Extract, Rosmarinus Officinalis (Rosemary) Extract, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Hydroxyethyl Ethylcellulose - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.1
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-044 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 2.90 g in 30 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.50 g in 30 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE 0.88 g in 30 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE (UNII: 92RU3N3Y1O) MICA (UNII: V8A1AW0880) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ACAI (UNII: 46AM2VJ0AW) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) YELLOW WAX (UNII: 2ZA36H0S2V) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM (UNII: 7FLD91C86K) ADENOSINE (UNII: K72T3FS567) CRANBERRY (UNII: 0MVO31Q3QS) BEACH STRAWBERRY (UNII: 98542F2TQS) RASPBERRY (UNII: 4N14V5R27W) BLACKBERRY (UNII: 8A6OMU3I8L) DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) THYME (UNII: CW657OBU4N) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) ROSEMARY (UNII: IJ67X351P9) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-044-01 30 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2011 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture