BLISTEX  COMPLETE MOISTURE- 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®
Complete Moisture®

Drug Facts

Active ingredients Purpose
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

behenoyl stearic acid, butylparaben, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, ethylparaben, flavor, glycerin, jojoba esters, lecithin, methylparaben, microcrystalline wax, ozokerite, panthenol, petrolatum, propylparaben, purified water, sodium borate, sodium saccharin, squalane

Other information

PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton

NDC 10157-9877-1

Blistex®
LIP PROTECTANT/SUNSCREEN

COMPLETE
MOISTURE®

Moisture Plus
Ultra-Hydrating Ingredients

Penetrates To Quench Dry Lips

NET WT. .15 oz (4.25g)

SPF 15

PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton
BLISTEX   COMPLETE MOISTURE
octinoxate, oxybenzone, and dimethicone stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9877
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.5 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
water (UNII: 059QF0KO0R)  
saccharin sodium (UNII: SB8ZUX40TY)  
squalane (UNII: GW89575KF9)  
panthenol (UNII: WV9CM0O67Z)  
microcrystalline wax (UNII: XOF597Q3KY)  
glycerin (UNII: PDC6A3C0OX)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
petrolatum (UNII: 4T6H12BN9U)  
7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H)  
ceresin (UNII: Q1LS2UJO3A)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10157-9877-1 1 in 1 CARTON
1 4.25 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 03/05/2003
Labeler - Blistex Inc. (005126354)
Establishment
Name Address ID/FEI Business Operations
Blistex Inc. 005126354 MANUFACTURE(10157-9877)

Revised: 11/2013
Document Id: 223035cd-996b-4645-9889-4cf8234b93a9
Set id: 99ec228c-d039-4a0b-a965-a3ac57889d4d
Version: 1
Effective Time: 20131112
 
Blistex Inc.