HEBE LUCA BB- octinoxate, titanium dioxide, octisalate, zinc oxide cream 
PICOSTECH 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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Drug Facts

Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide

Water, etc.

Sunscreen

keep out of reach of the children

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

Spread an appropriate amount on the face and absorb it.

for external use only


label

HEBE LUCA BB 
octinoxate, titanium dioxide, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72149-0012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.075 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72149-0012-120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/13/201806/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/201806/26/2018
Labeler - PICOSTECH Co.,Ltd. (557816754)
Registrant - PICOSTECH Co.,Ltd. (557816754)
Establishment
NameAddressID/FEIBusiness Operations
PICOSTECH Co.,Ltd.557816754manufacture(72149-0012) , label(72149-0012) , pack(72149-0012)
Establishment
NameAddressID/FEIBusiness Operations
JM Medi Bio694857727relabel(72149-0012)

Revised: 6/2018
 
PICOSTECH Co.,Ltd.