MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 70ML- octinoxate, octocrylene, octisalate, avobenzone lotion
MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 40ML- octinoxate, octocrylene, octisalate, avobenzone lotion
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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MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 PLUS

ACTIVE INGREDIENTS

Octinoxate 7%

Octocrylene 5%

Octisalate 4.5%

Avobenzone 4%

PURPOSE

Sunscreen

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

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to Remove.

Stop use and ask a doctor

If rash occurs

Directions

apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water-resistant sunscreen if swimming or sweating

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 SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10a.m. – 2p.m.
wear long-sleeved shirts, pants, hats and sunglasses

Other information

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENTS

Water, Butylene Glycol, Alcohol Denat., Helichrysum Arenarium Extract, Methyl Methacrylate Crosspolymer, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Silica, Althaea Rosea Root Extract, Caprylyl Glycol, Glycerin, Nylon-12, Ethylhexylglycerin, Nelumbo Nucifera Flower Extract, Portulaca Oleracea Extract, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexanediol, BHT, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide, Rosa Davurica Bud Extract, Potassium sorbate, Pentylene Glycol, Chrysanthemum Indicum flower Extract, Camellia Japonica Flower Extract, VP/Hexadecene Copolymer, Psidium Guajava Leaf Extract, Abronia Villosa Leaf Extract, Aloe Barbadensis Leaf Extract, Cinchona Succirubra Bark Extract, Prunus Mume Flower Extract, Cyclopentasiloxane, Salvia Officinalis (Sage) Water, Calendula officinalis flower water, Pelargonium Graveolens Flower Water, Camellia Sinensis Leaf Extract, Rhodiola Rosea Root Extract, Morus Alba Fruit Extract, Diospyros Kaki Leaf Extract, Pueraria Lobata Root Extract, Cinnamomum Cassia Bark Extract, Artemisia princeps Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Methicone, Betaine

Questions or comments?

Visit www.missaus.com or call 1-888-985-9887(Ext 104)

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 PLUS 70ML

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 _ 70ML (1)

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 PLUS 40ML

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 _ 40ML (1)

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 70ML
octinoxate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13733-401
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.9 g in 70 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.5 g in 70 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.15 g in 70 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g in 70 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HELICHRYSUM ARENARIUM FLOWER (UNII: GN27F71368)
METHYL METHACRYLATE (UNII: 196OC77688)
BEMOTRIZINOL (UNII: PWZ1720CBH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCEA ROSEA ROOT (UNII: 7PBQ0GP92D)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
NYLON-12 (UNII: 446U8J075B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PORTULACA OLERACEA SEED (UNII: M08917G08Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CINCHONA PUBESCENS BARK (UNII: S96N10R972)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ROSA DAVURICA FLOWER BUD (UNII: XR42W0H5IU)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
PSIDIUM GUAJAVA LEAF (UNII: PM0F263X0Y)
ABRONIA VILLOSA LEAF (UNII: A138B5260A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PRUNUS MUME FLOWER (UNII: 2N8872050J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SAGE OIL (UNII: U27K0H1H2O)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN)
WHITE MULBERRY (UNII: MN25R0HH5A)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
CHINESE CINNAMON (UNII: WS4CQ062KM)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BETAINE (UNII: 3SCV180C9W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13733-401-01	70 g in 1 CARTON; Type 0: Not a Combination Product	06/18/2018	12/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/18/2018	12/09/2018

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 40ML
octinoxate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13733-402
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 g in 40 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 40 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 g in 40 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.6 g in 40 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
HELICHRYSUM ARENARIUM FLOWER (UNII: GN27F71368)
METHYL METHACRYLATE (UNII: 196OC77688)
BEMOTRIZINOL (UNII: PWZ1720CBH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCEA ROSEA ROOT (UNII: 7PBQ0GP92D)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
NYLON-12 (UNII: 446U8J075B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CINCHONA PUBESCENS BARK (UNII: S96N10R972)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
PORTULACA OLERACEA SEED (UNII: M08917G08Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ROSA DAVURICA FLOWER BUD (UNII: XR42W0H5IU)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
PSIDIUM GUAJAVA LEAF (UNII: PM0F263X0Y)
ABRONIA VILLOSA LEAF (UNII: A138B5260A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PRUNUS MUME FLOWER (UNII: 2N8872050J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SAGE OIL (UNII: U27K0H1H2O)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN)
WHITE MULBERRY (UNII: MN25R0HH5A)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
CHINESE CINNAMON (UNII: WS4CQ062KM)
CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BETAINE (UNII: 3SCV180C9W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13733-402-01	40 g in 1 CARTON; Type 0: Not a Combination Product	06/18/2018	12/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/18/2018	12/09/2018

Labeler - Able C&C Co., Ltd. (689540284)

Registrant - Able C&C Co., Ltd. (689540284)

Name	Address	ID/FEI	Business Operations
Establishment
CIT Co., LTD		690081646	manufacture(13733-401, 13733-402)

Revised: 12/2018

Document Id: 7cee6e98-441e-2d63-e053-2991aa0ae3a0

Set id: 36acb498-c94f-0c7a-e054-00144ff8d46c

Version: 11

Effective Time: 20181213

Able C&C Co., Ltd.