BLANC DIVA MULTI PROTECTION FITTING SUNBASE by AHNNK GLOBAL Co., Ltd. / Cosmax, Inc.

BLANC DIVA MULTI PROTECTION FITTING SUNBASE by

Drug Labeling and Warnings

BLANC DIVA MULTI PROTECTION FITTING SUNBASE by is a Otc medication manufactured, distributed, or labeled by AHNNK GLOBAL Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLANC DIVA MULTI PROTECTION FITTING SUNBASE- zinc oxide, titanium dioxide cream 
AHNNK GLOBAL 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.

----------

ACTIVE INGREDIENTS

Zinc Oxide 11.23%
Titanium Dioxide 4.83%

INACTIVE INGREDIENTS

Water, Isononyl Isononanoate, C12-15 Alkyl Benzoate, Isododecane, Butyloctyl Salicylate, Acrylates Copolymer, Caprylyl Methicone, Trimethylsiloxysilicate, Dipropylene Glyco, Glycerin, Methyl Trimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,
1,2-Hexanediol, Polyglyceryl-2 Isostearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite,  Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Silica, Coco-Caprylate/Caprate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Poly C10-30 Alkyl Acrylate, Magnesium Sulfate, Sorbitan Sesquioleate, Dimethicone/Vinyl Dimethicone Crosspolymer,  Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Triethoxycaprylylsilane, Octyldodecanol, Chlorella Vulgaris Extract, Glucose, Aluminum Hydroxide, Polyglyceryl-6 Polyhydroxystearate, Sorbitan Isostearate, Stearic Acid, Polyglyceryl-2 Dipolyhydroxystearate,Butylene Glycol, Fructooligosaccharides, Fructose, Iron Oxides(CI 77492), Polyglyceryl-4 Isostearate, Isopropyl Titanium Triisostearate, Ethylhexylglycerin, Polyglycerin-6, Trisodium Ethylenediamine Disuccinate,Iron, Oxides (CI 77491), Tocopherol, Ascorbyl Palmitate

PURPOSE

Sunscreen

WARNINGS

For external use only
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps skin protection from UV rays.

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.

Other Information

■ Do not store this product in an inappropriate place such as high, low temperatures or under direct sun light

Questions

■ https://www.blancdiva.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLANC DIVA MULTI PROTECTION FITTING SUNBASE 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82485-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.23 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.83 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Isododecane (UNII: A8289P68Y2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82485-050-02	1 in 1 CARTON	02/01/2022	12/24/2022
1	NDC: 82485-050-01	50 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	02/01/2022	12/24/2022

Labeler - AHNNK GLOBAL Co., Ltd. (695794480)

Registrant - AHNNK GLOBAL Co., Ltd. (695794480)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(82485-050)

Revised: 12/2022

Document Id: 3e157d79-2401-4f40-9326-80da874f20b8

34390-5

Set id: bc212228-46cd-4583-93db-b9fedb49128b

Version: 2

Effective Time: 20221226