ESMIA BB CARAMEL 31- titanium dioxide, octinoxate, octisalate cream

ESMIA BB Caramel 31 by

Drug Labeling and Warnings

ESMIA BB Caramel 31 by is a Otc medication manufactured, distributed, or labeled by Bs Cosmetics Co.,ltd., EYESOME. Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients 

Active ingredients: Titanium Dioxide 9.36%, Ethylhexyl Methoxycinnamate 5.00%, Ethylhexyl Salicylate 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water,Propylene Glycol,Mineral Oil,Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate,
Niacinamide,Cetyl PEG/PPG-10/1 Dimethicone,Dimethicone,Cyclopentasiloxane,Glycerin,Sorbitan Sesquioleate
Magnesium Sulfate,Microcrystalline Wax,Mica (CI 77019),Phenyl Trimethicone,Aluminum Hydroxide,Cyclohexasiloxane,Disteardimonium Hectorite
Dimethicone/Vinyl Dimethicone Crosspolymer,Caprylyl Glycol,Butylene Glycol,Silica Dimethyl Silylate,Zinc Stearate,Triethoxycaprylylsilane,Stearic Acid
PEG-10 Dimethicone Crosspolymer,Tocopheryl Acetate,Allantoin,Caprylhydroxamic Acid,PEG-10 Dimethicone,Sodium Citrate,Hydroxyethylcellulose
Aloe Barbadensis Leaf Juice,Bisabolol,Butyrospermum Parkii (Shea Butter),Macadamia Ternifolia Seed Oil,Simmondsia Chinensis (Jojoba) Seed Oil
Adenosine,Argania Spinosa Kernel Oil,Farnesol,Farnesyl Acetate,Helianthus Annuus (Sunflower) Seed Oil,Panthenyl Triacetate,Sodium Hyaluronate
Sophora Japonica Fruit Extract,Ceramide NP,Hydrogenated Lecithin,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499),Fragrance)

Purpose

Purpose: Sunscreen

Warnings

Warnings:

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 use and ask a doctor if rash occurs.

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Uses:

Helps prevent sunburn

Directions:

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESMIA BB CARAMEL 31 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72600-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.74 g  in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.00 g  in 40 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.80 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72600-150-02	1 in 1 CARTON	09/01/2018
1	NDC: 72600-150-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2018

Labeler - Bs Cosmetics Co.,ltd. (694791429)

Registrant - Bs Cosmetics Co.,ltd. (694791429)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME. Co.,Ltd.		557795360	manufacture(72600-150)