COVER YOUR MOUTH SPF 8 LIP PROTECTOR

Dosage form: lipstick
Ingredients: TITANIUM DIOXIDE 1.8g in 100g
Labeler: ORIGINS NATURAL RESOURCES INC.
NDC Code: 59427-575

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.

active ingredient: titanium dioxide 1.80%

inactive ingredients: canola oil [] beeswax (cera alba) [] lecithin [] mentha piperita (peppermint) essential oil (olea) [] cocos nucifera (coconut) oil [] vanilla planifolia [] aloe barbadensis (aloe) leaf juice [] lauroyl lysine [] tocopherol (vitamin e) [] aluminum stearate [] stearic acid

warning: stop use if signs of irritation appear and check with doctor.

PRINCIPAL DISPLAY PANEL


ORIGINS

COVER YOUR MOUTH

LIP PROTECTOR

WITH SPF 8

NT WT 0.15 OZ./ 4.5 G



origins natural resources inc.
new york, ny 10022



COVER YOUR MOUTH  SPF 8 LIP PROTECTOR
titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-575
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CANOLA OIL 
WHITE WAX 
LECITHIN, SOYBEAN 
PEPPERMINT OIL 
COCONUT OIL 
VANILLA 
LAUROYL LYSINE 
ALPHA-TOCOPHEROL 
ALUMINUM STEARATE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:59427-575-014.5 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/1999
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIOperations
PRIVALE LABEL SELECT LTD005415463manufacture

Revised: 07/2011
 
ORIGINS NATURAL RESOURCES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)