MISSHA M PERFECT COVER BB NO 13- zinc oxide, titanium dioxide, octinoxate cream

MISSHA M Perfect Cover BB No 13 by

Drug Labeling and Warnings

MISSHA M Perfect Cover BB No 13 by is a Otc medication manufactured, distributed, or labeled by Able C&C Co., Ltd., Hanacos Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredients: Octinoxate 7.5%, Zinc Oxide 7%, Titanium Dioxide 4.19%

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 ocurs

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, regulary use a sunscreen with SPF value of 15 or higher and other sun protection measures including:

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

Other Information

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

Questions or comments?

visit www.misshaus.com or call 1-888-985-9887(Ext 104)

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Propylene Glycol, Caprylic/Capric Triglyceride, PEG-10 Dimethicone, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Mineral Oil, Polyethylene, Talc, Phenyl Trimethicone, Beeswax (Cera Alba), Sodium Chloride, Ferric Oxide Yellow, Methylparaben, Dimethicone, Ferric Oxide Red, Propylparaben, Rosa Canina Fruit Oil, Squalane, Macadamia Ternifolia Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cyclotetrasiloxane, Ferrosoferric oxide, Disodium EDTA, Adenosine, Algae Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ceramide NP, Butylene Glycol, Fagus Sylvatica Bud Extract, Hydrolyzed collagen, Caprylyl Glycol, Benzyl Alcohol, 1,2-Hexanediol, Caprylhydroxamic Acid, Tocopherol, Benzoic Acid, Sodium Hyaluronate, Phenoxyethanol, Tropolone, Fragrance (Parfum), Butylphenyl Methylpropional, Benzyl Salicylate, Hydroxycitronellal, Alpha-Isomethyl Ionone, Hexyl Cinnamal, Linalool, Citronellol, Limonene

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MISSHA M PERFECT COVER BB NO 13 
zinc oxide, titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13733-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.07 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0419 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MACADAMIA OIL (UNII: 515610SU8C)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CERAMIDE 6 II (UNII: F1X8L2B00J)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZOIC ACID (UNII: 8SKN0B0MIM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TROPOLONE (UNII: 7L6DL16P1T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TALC (UNII: 7SEV7J4R1U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SQUALANE (UNII: GW89575KF9)
ARBUTIN (UNII: C5INA23HXF)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ABRONIA VILLOSA LEAF (UNII: A138B5260A)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LAMINARIA HYPERBOREA (UNII: NXA595GQ1K)
ROSEMARY (UNII: IJ67X351P9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
JOJOBA OIL (UNII: 724GKU717M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ADENOSINE (UNII: K72T3FS567)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
MINERAL OIL (UNII: T5L8T28FGP)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13733-141-01	50 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2019
2	NDC: 13733-141-02	20 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2019
3	NDC: 13733-141-03	1 g in 1 PACKET; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Hanacos Co., Ltd.		690177857	manufacture(13733-141)