ALL AGLOW PERFECT CUSHION FOUNDATION- titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid 
Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory

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.

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Titanium Dioxide 9%

Octyl methoxycinnamate 7%

Octyl Salicylate 4.8%

Octocrylene 2%

Zinc Oxide 2%

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

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

SUNSCREEN

Keep out of reach of children

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

label

ALL AGLOW PERFECT CUSHION  FOUNDATION
titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58544-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.8 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58544-001-0115 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/25/2016
Labeler - Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory (687772475)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory688235645manufacture(58544-001)

Revised: 8/2016
Document Id: 3b4a56aa-5341-675b-e054-00144ff8d46c
Set id: 3aeb55c7-2907-6dd7-e054-00144ff8d46c
Version: 8
Effective Time: 20160825
 
Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory