ESMIA BB BUFF 25- titanium dioxide, octinoxate, octisalate cream 
Bs Cosmetics 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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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,Mica (CI 77019),Cetyl PEG/PPG-10/1 Dimethicone,Dimethicone
Cyclopentasiloxane,Glycerin,Sorbitan Sesquioleate,Magnesium Sulfate,Microcrystalline Wax,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

Image of carton

ESMIA BB BUFF 25 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72600-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.74 g  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.8 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72600-180-021 in 1 CARTON09/01/2018
1NDC:72600-180-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/201806/10/2021
Labeler - Bs Cosmetics Co.,ltd. (694791429)

Revised: 6/2021
 
Bs Cosmetics Co.,ltd.