ALL AGLOW PERFECT CUSHION FOUNDATION- titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid

All Aglow Perfect Cushion by

Drug Labeling and Warnings

All Aglow Perfect Cushion by is a Otc medication manufactured, distributed, or labeled by Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 9%

Octyl methoxycinnamate 7%

Octyl Salicylate 4.8%

Octocrylene 2%

Zinc Oxide 2%

INDICATIONS & USAGE

USES

Helps prevent sunburn.
If used as directed with other sun protection measures - See
Directions- decreases the risk of skin cancer and early skin aging
caused by the sun.

Warnings

WARNINGS

– For External use only.
– Keep out of eyes. Rinse with water to remove.
– Stop use if a rash develops. Consult a physician.
.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.

Other information

• Protect the product in this container from excessive heat and sun.

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

PURPOSE

SUNSCREEN

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If product is swallowed, get medical help or contact a poison control center right away

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL AGLOW PERFECT CUSHION  FOUNDATION
titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid

Product 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)