BLISTEX  HERBAL ANSWER- octinoxate, oxybenzone, and petrolatum 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®
Herbal Answer®

Drug Facts

Active ingredientsPurpose
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen
Petrolatum 43% (w/w)Lip protectant

Uses

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

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

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

aloe barbadensis leaf extract (decolorized), beeswax, butyrospermum parkii (shea) butter, cetyl alcohol, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, isopropyl lanolate, lanolin, methylparaben, microcrystalline wax, ozokerite, paraffin, persea gratissima (avocado) oil, phenyl trimethicone, propylparaben, simmondsia chinensis (jojoba) seed oil

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

The Soothing
Herbal
Alternative

Blistex®

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton
BLISTEX   HERBAL ANSWER
octinoxate, oxybenzone, and petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9868
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
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum43 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax (UNII: 2ZA36H0S2V)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LANOLIN (UNII: 7EV65EAW6H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
microcrystalline wax (UNII: XOF597Q3KY)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CHAMOMILE (UNII: FGL3685T2X)  
ceresin (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9868-11 in 1 CARTON06/01/199912/07/2022
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/01/199912/07/2022
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9868)

Revised: 12/2022
Document Id: c19bd902-d0a7-40e8-9121-ffe873890105
Set id: 1fdc0d68-9240-4e23-83dc-41df010ed2c3
Version: 4
Effective Time: 20221208
 
Blistex Inc.