ONALT PURE MILD SUNCREAM- titanium dioxide, zinc oxide cream 
HnB9 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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titanium dioxide, zinc oxide

UV protection

skin whitening

wrinkle care

KEEP OUT OF REACH OF THE CHILDREN

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

Water
C12-15 Alkyl Benzoate
Cyclopentasiloxane
Glycerin
Methylpropanediol
Cetyl PEG/PPG-10/1 Dimethicone
Aluminum Hydroxide
Polyhydroxystearic Acid
Niacinamide
Cetyl Dimethicone
Sea Water
Cetyl Ethylhexanoate
Sorbitan Trioleate
Stearic Acid
Isostearic Acid
Sorbitan Sesquioleate
Trifluoropropyl Dimethicone
Benzyl Glycol
Disteardimonium Hectorite
Ozokerite
Sodium Chloride
Butylene Glycol
Silica Dimethyl Silylate
Polymethylsilsesquioxane
Fragrance
Silica
Tocopheryl Acetate
Sargassum Fulvellum Extract
Ethylhexylglycerin
Hizikia Fusiforme Extract
1,2-Hexanediol
Adenosine
Disodium EDTA
Ethylhexylglycerin

apply proper amount to the skin

label

ONALT PURE MILD SUNCREAM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80564-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80564-0001-150 mL in 1 TUBE; Type 0: Not a Combination Product09/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/22/2020
Labeler - HnB9 Co., Ltd. (694434516)
Registrant - HnB9 Co., Ltd. (694434516)
Establishment
NameAddressID/FEIBusiness Operations
HnB9 Co., Ltd.694434516manufacture(80564-0001)

Revised: 9/2020
Document Id: afdd5db8-5ad6-f71a-e053-2a95a90a82a5
Set id: afdd2516-7411-c93c-e053-2995a90a8646
Version: 1
Effective Time: 20200921
 
HnB9 Co., Ltd.