IPKN TWINKLE FLASH CREAM- octinoxate, octisalate, avobenzone cream 
Inel Cosmetics Co., Ltd.

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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Drug Facts

OCTINOXATE 5.00%
OCTISALATE 3.00%
AVOBENZONE 1.00%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure.

Reapply at least every two hours

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

WATER
CYCLOPENTASILOXANE
BUTYLENE GLYCOL
MICA
TITANIUM DIOXIDE
4-METHYLBENZYLIDENE CAMPHOR
GLYCERIN
ISODECYL NEOPENTANOATE
C12-15 ALKYL BENZOATE
OCTYLDODECYL NEOPENTANOATE
BEHENYL ALCOHOL
POTASSIUM CETYL PHOSPHATE
METHYL METHACRYLATE CROSSPOLYMER
ISOAMYL P-METHOXYCINNAMATE
POLYETHYLENE
HYDROGENATED PALM GLYCERIDES
CETEARYL ALCOHOL
POLYSORBATE 60
BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE
GLYCERYL CAPRYLATE
CAPRYLYL GLYCOL
FRAGRANCE
XANTHAN GUM
MICROCRYSTALLINE CELLULOSE
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
TRIETHOXYCAPRYLYLSILANE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
SQUALANE
DISODIUM EDTA
BHT
CELLULOSE GUM
TIN OXIDE
ROSA CENTIFOLIA FLOWER WATER
CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT
SORBITAN ISOSTEARATE
VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT
SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT

image description

IPKN TWINKLE FLASH CREAM 
octinoxate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.5 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.5 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ENZACAMENE (UNII: 8I3XWY40L9)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DOCOSANOL (UNII: 9G1OE216XY)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
AMILOXATE (UNII: 376KTP06K8)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
TANGERINE (UNII: KH3E3096OO)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
VACCINIUM MYRTILLUS FRUITING TOP (UNII: QT6362QVN8)  
SUGARCANE (UNII: 81H2R5AOH3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-124-021 in 1 CARTON06/14/201602/01/2018
1NDC:43526-124-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/14/201602/01/2018
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(43526-124)

Revised: 2/2018
Document Id: 9866e8af-9609-4d26-92e1-bd3728602913
Set id: dfd1de16-1d28-479f-a50b-bd5c8418f3f3
Version: 2
Effective Time: 20180201
 
Inel Cosmetics Co., Ltd.