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

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN by

Drug Labeling and Warnings

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN by is a Otc medication manufactured, distributed, or labeled by ABLE C&C CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

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

WARNINGS

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:
Keep out of reach of children.

INDICATIONS & USAGE

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 & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN  SPF45 PA PLUS PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13733-014
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.4 mL  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13733-014-01	50 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2011

Labeler - ABLE C&C CO., LTD. (689540284)

Registrant - ABLE C&C CO., LTD. (689540284)

Establishment
Name	Address	ID/FEI	Business Operations
ABLE C&C CO., LTD.		689540284	manufacture