Label: ALL AGLOW PERFECT CUSHION FOUNDATION- titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58544-001-01 - Packager: Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory
- 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 August 25, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- Warnings
- Directions
- Other information
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Inactive ingredients
WATER, CYCLOPENTASILOXANE (CYCLOMETHICONE), DIPHENYLSILOXY
PHENYL TRIMETHICONE, CYCLOHEXASILOXANE (CYCLOMETHICONE),
C12-15 ALKYL BENZOATE, NIACINAMIDE, CAPRYLYL METHICONE,
TRIMETHYLSILOXYSILICATE, PEG-30 DIPOLYHYDROXYSTEARATE,
PEG-10 DIMETHICONE, BUTYLENE GLYCOL, VINYL
DIMETHICONE/METHICONE SILSESQUIOXANE CRTOSSPOLYMER,
SODIUM CHLORIDE, QUATERNIUM-18 BENTONITE,
ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE
COPOLYMER, POLYMETHYL METHACRYLATE, IRON OXIDE,
DIMETHICONE, ACRYLATES/DIMETHICONE COPOLYMER, BORON
NITRIDE, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE,
ALUMINA (CI 77002), CITRUS MEDICA LIMONUM (LEMON) PEEL
OIL, ADENOSINE, HONEY, LAVANDULA ANGUSTIFOLIA (LAVENDER)
OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL,
EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM DULCIS
(ORANGE) PEEL OIL, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL,
HYDROGENATED LECITHIN, 1,2-HEXANEDIOL, CHOLESTEROL,
PEG-800, GLYCERIN, POLYSORBATE 20, SH-OLIGOPEPTIDE-1,
SH-POLYPEPTIDE-1, SH-POLYPEPTIDE-8, SH-POLYPEPTIDE-9,
SH-POLYPEPTIDE-45, SH-OLIGOPEPTIDE-2, SH-POLYPEPTIDE-22. - PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALL AGLOW PERFECT CUSHION FOUNDATION
titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58544-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.8 mg in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 mg in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 9 mg in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) PEG-80 STEARATE (UNII: 1X2OAT3BFK) EUCALYPTUS OIL (UNII: 2R04ONI662) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON) ALUMINUM HYDROXIDE SULFATE (AL(OH)(SO4)) (UNII: 9QO62ZS7VO) CYCLOMETHICONE 6 (UNII: XHK3U310BA) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NIACINAMIDE (UNII: 25X51I8RD4) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENTOQUATAM (UNII: 7F465U79Q1) STEARYL CAPRYLATE (UNII: 06TS6O9194) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) BROWN IRON OXIDE (UNII: 1N032N7MFO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) CHLORPHENESIN (UNII: I670DAL4SZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CHOLESTEROL (UNII: 97C5T2UQ7J) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) ORANGE OIL (UNII: AKN3KSD11B) ROSEMARY OIL (UNII: 8LGU7VM393) LAVENDER OIL (UNII: ZBP1YXW0H8) HONEY (UNII: Y9H1V576FH) JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) ADENOSINE (UNII: K72T3FS567) NEPIDERMIN (UNII: TZK30RF92W) BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V) MECASERMIN (UNII: 7GR9I2683O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58544-001-01 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 08/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/25/2016 Labeler - Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory (687772475) Establishment Name Address ID/FEI Business Operations Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory 688235645 manufacture(58544-001)