BLISTEX  ULTRA RICH HYDRATION- 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®
Ultra-Rich Hydration

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.8% (w/w)Sunscreen
Oxybenzone 3.0% (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

Other information

Inactive ingredients

aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea butter), ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, isostearoyl hydrolyzed silk, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, theobroma cacao (cocoa) seed butter, titanium dioxide, tocopheryl acetate, triticum vulgare (wheat) germ oil

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

NDC 10157-8015-1
Blistex®
LIP PROTECTANT/SUNSCREEN

ULTRA-RICH
HYDRATION

NEW!

Dual-Layer Balm

INNER: Deeply Hydrates With
80% Moisturizers

OUTER: Smoothes & Seals
With Lush Protectants

SPF 15

NET WT. .13 oz (3.69g)

Principal Display Panel - 3.69 g Cylinder Blister Pack
BLISTEX   ULTRA RICH HYDRATION
octinoxate, oxybenzone, and dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.8 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax (UNII: 2ZA36H0S2V)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
microcrystalline wax (UNII: XOF597Q3KY)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SHEA BUTTER (UNII: K49155WL9Y)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHEAT GERM OIL (UNII: 14C97E680P)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CHAMOMILE (UNII: FGL3685T2X)  
ceresin (UNII: Q1LS2UJO3A)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SACCHARIN (UNII: FST467XS7D)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-8015-11 in 1 BLISTER PACK
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/30/2014
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-8015)

Revised: 4/2014
Document Id: 07932d6e-8b02-4207-b680-f0a008693c65
Set id: ab459485-834d-40a0-b7d8-5221aa5ee4a5
Version: 1
Effective Time: 20140416
 
Blistex Inc.