BLISTEX  NURTURE AND NOURISH- octinoxate, oxybenzone, and dimethicone stick 
Blistex 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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Blistex®
Nurture & Nourish

Drug Facts

Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

beeswax, euterpe oleracea (acai) fruit extract, flavor, helianthus annuus (sunflower) seed oil, hydrogenated vegetable oil, jojoba esters, lanolin alcohol, lycium barbarum (goji) fruit extract, microcrystalline wax, octyldodecanol, olea europaea (olive) fruit oil, ozokerite, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, saccharomyces/copper ferment, saccharomyces/magnesium ferment, saccharomyces/potassium ferment, saccharomyces/zinc ferment, sorbic acid, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate, vitis vinifera (grape) seed oil

Other information

PRINCIPAL DISPLAY PANEL - 4.25g Stick Carton

Exceptionally
Healthy Lips
Inside & Out

Blistex®

PRINCIPAL DISPLAY PANEL - 4.25g Stick Carton
BLISTEX   NURTURE AND NOURISH
octinoxate, oxybenzone, and dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9826
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax (UNII: 2ZA36H0S2V)  
acai (UNII: 46AM2VJ0AW)  
sunflower oil (UNII: 3W1JG795YI)  
lanolin alcohols (UNII: 884C3FA9HE)  
lycium barbarum fruit (UNII: 930626MWDL)  
microcrystalline wax (UNII: XOF597Q3KY)  
octyldodecanol (UNII: 461N1O614Y)  
olive oil (UNII: 6UYK2W1W1E)  
petrolatum (UNII: 4T6H12BN9U)  
phenoxyethanol (UNII: HIE492ZZ3T)  
castor oil (UNII: D5340Y2I9G)  
saccharin (UNII: FST467XS7D)  
sorbic acid (UNII: X045WJ989B)  
squalane (UNII: GW89575KF9)  
cocoa butter (UNII: 512OYT1CRR)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
grape seed oil (UNII: 930MLC8XGG)  
ceresin (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9826-11 in 1 CARTON
14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/31/2013
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9826)

Revised: 3/2013
Document Id: c30bc026-884c-4ded-9798-07390a44cdb9
Set id: 78a53063-e2ba-4fa3-8c17-7bc8e60c1306
Version: 1
Effective Time: 20130325
 
Blistex Inc.