EXTEN-10 INSTANT YOUTH BOOSTING MOISTURIZER SPF 15- octinoxate, octisalate, avobenzone cream 
GOOD SKIN DERMACARE

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: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00%


DIRECTIONS: ON CLEAN DRY SKIN, SMOOTH A LIBERAL AMOUNT OVER ENTIRE FACE AND NECK. APPLY PRIOR TO SUN EXPOSURE FOR DAILY SPF PROTECTION. REAPPLY IF EXPOSED TO PROLONGED SN EXPOSURE

WARNING: KEEP OUT OF EYES. STOP USE IN IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:

EXTEN-10

INSTANT YOUTH BOOSTING MOISTURIZER SPF 15

1.7 FL OZ/OZ/LIQ/ 50 ML




GOOD SKIN LABS
GOOD SKIN DERMACARE DIST

NEW YORK, NY 10022

 
FOLDING CARTON



EXTEN-10  INSTANT YOUTH BOOSTING MOISTURIZER SPF 15
octinoxate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68758-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.00 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68758-009-011 in 1 CARTON
1NDC:68758-009-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/2010
Labeler - GOOD SKIN DERMACARE (143367634)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
PADC 1110482184manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636manufacture, label, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 5/2010
Document Id: 24a1d522-1d6d-4ec2-a80e-971908135b34
Set id: d0cbd790-c401-42a3-8a5b-9ecfb2f74bd4
Version: 3
Effective Time: 20100514
 
GOOD SKIN DERMACARE