OTHREE 50 WHITENING- titanium dioxide, zinc oxide, octinoxate, octocrylene cream 
CELLAB CO., LTD.

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ACTIVE INGREDIENT

Octinoxate 7.5%

Octocrylene 6%

Zinc Oxide 5%

Titanium Dioxide 4.92%

INACTIVE INGREDIENT

Water

Cyclomethicone 5

Cetyl Peg/ppg-10/1 dimethicone (hlb2)

sodium chroride

Niacinamide

Disteardimonium hectorite

Polyglyceryl-4 isostearate

sorbitan dioleate

phenyl trimethicone

acai

chamomile

rosemary

lavandula angustifolia flower

stearic acid

aluminum hydroxide

silicon dioxide

magnesium aluminum silicate

dimethicone/vinyl dimethicone crosspolymer

dimethicone

microcrystalline wax

yellow wax

sorbitan isostearate

hexyl laurate

allantoin

dipropylene glycol

ferric oxide yellow

ferric oxide red

.alpha.-tocopherol acetate

propylparaben

methylparaben

methylparaben

edetate disodium

PURPOSE

Sunscreen

WARNINGS

For external use only. Avoid eyes: if contact or adverse reaction occurs, rinse well and consult physician immediately. Do not use on infants.

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Uses

As the final step in skin care, apply a proper amount evenly over the entire face and neck to protect against harmful UV rays. Apply 30 minutes before sun exposure for more effective result.

Directions

As the final step in skin care, apply a proper amount evenly over the entire face and neck to protect against harmful UV rays. Apply 30 minutes before sun exposure for more effective result.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

OTHREE 50 WHITENING 
titanium dioxide, zinc oxide, octinoxate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57557-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.936 g  in 80 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 80 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 80 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.8 g  in 80 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57557-100-021 in 1 CARTON04/03/201310/01/2022
1NDC:57557-100-0180 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/03/201310/01/2022
Labeler - CELLAB CO., LTD. (688195494)
Registrant - CELLAB CO., LTD. (688195494)
Establishment
NameAddressID/FEIBusiness Operations
CELLAB CO., LTD.688195494manufacture(57557-100)

Revised: 1/2024
 
CELLAB CO., LTD.