MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS- octinoxate cream 
ABLE C&C 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

Active ingredients: Octinoxate 7%, Octisalate 4.8%, Phenylbenzimidazole Sulfonic Acid 4%

INACTIVE INGREDIENTS:
Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Glyceryl Stearate, Cetearyl Olivate, Sorbitan Olivate, Sodium Hydroxide, Dimethicone, Polyacrylate-13, PEG-100 Stearate, Polyisobutene, Sorbitan Stearate, Panthenol, Aloe Barbadensis Leaf Juice, Sorbitan Isostearate, Polysorbate 20, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Water, Portulaca Oleracea Extract, Nelumbo Nucifera Flower Extract, Rosa Davurica Bud Extract, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Diospyros Kaki Leaf Extract, Pueraria Lobata Root Extract, Cinnamomum Cassia Bark Extract, Artemisia princeps Leaf Extract, Morus Alba Fruit Extract, BHT, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sun protection cream

WARNINGS:
For external use only.
Do not swallow.
Avoid contact with eyes.
Do not use on wounds or if you are allergic to any ingredients of this product.

Keep out of reach of children:
Keep out of reach of children.

INDICATION AND USAGE:
- At the last step of basic skin care, apply an appropriate amount evenly over the face. Pat lightly until fully absorbed.
- Apply evenly onto the face, neck, arms and legs where sun exposure occurs.
- Reapply during long exposure.

DOSAGE AND ADMINISTRATION:
Take appropriate amount according to your skin condition and apply every morning and night.

Image of carton

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN  SPF45 PA PLUS PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-014
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.4 mL  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
MORUS ALBA ROOT (UNII: CST1G9BZGD)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CUCUMBER (UNII: YY7C30VXJT)  
WITCH HAZEL (UNII: 101I4J0U34)  
PURSLANE (UNII: M6S840WXG5)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C)  
DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-014-0150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2011
Labeler - ABLE C&C CO., LTD. (689540284)
Registrant - ABLE C&C CO., LTD. (689540284)
Establishment
NameAddressID/FEIBusiness Operations
ABLE C&C CO., LTD.689540284manufacture

Revised: 11/2011
Document Id: 8b72633e-c1cd-4722-8c81-f82807e9605c
Set id: 7c0f359d-f89c-4fd6-855a-9463015b2fc9
Version: 1
Effective Time: 20111122
 
ABLE C&C CO., LTD.