HYDRA INTENSIVE BLEMISH BALM SPF30 PA - titanium dioxide octinoxate zinc oxide cream 
The Doctor's Cosmetic Inc

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:

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Portulaca Oleracea Extract, Citrus Grandis (Grapefruit) Peel Extract, Camellia Sinensis Leaf Extract

CAUTION: Keep away from children.

DIRECTION OF USE:

Apply thin layer of blemish balm onto all over the face.  Use fingertips to spread gently until it has been completely absorbed.


Label18c



LABEL

HYDRA INTENSIVE BLEMISH BALM SPF30 PA 
titanium dioxide octinoxate zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-7001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE3 mL  in 60 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 mL  in 60 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE0.3 mL  in 60 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43948-7001-160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2009
Labeler - The Doctor's Cosmetic Inc (687479378)
Registrant - The Doctor's Cosmetic Inc (687479378)
Establishment
NameAddressID/FEIBusiness Operations
The Doctor's Cosmetic Inc687479378manufacture

Revised: 10/2009
Document Id: 5be89c26-9877-40d5-910d-16f73be10ebd
Set id: 286182a5-f383-4b14-9ddd-0a63942e371e
Version: 1
Effective Time: 20091001
 
The Doctor's Cosmetic Inc