CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK- octinoxate, oxybenzone, camphor (synthetic), white petrolatum 
Carma Laboratories, Inc.

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Carmex Classic Lip Balm Medicated Free Wintergreen Stick, kit

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Uses

• helps protect against sunburn
• higher SPF gives more sunburn protection

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.

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: • after 80 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours
• children under 2 years of age: ask a doctor

Inactive Ingredients

petrolatum, lanolin, euphorbia cerifera (candelilla) wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

Drug Facts

Active Ingredients

Camphor 1.70%

White Petrolatum 45.30%

Purpose

External Analgesic

Lip Protectant

Uses

Warnings

When using this product:

keep out of eyes.

Stop use and ask a doctor if:

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on:

• deep puncture wounds • serious burns • animal bites

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply to lips not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Inactive Ingredients

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

Package Labeling:10210-0047-1

Kit

Package labeling:10210-0038-0

tube

Package Labeling:10210-0033-1

Box

CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK 
octinoxate, oxybenzone, camphor (synthetic), white petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0047
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0047-11 in 1 KIT06/20/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CYLINDER 4.25 g
Part 21 TUBE 10 g
Part 1 of 2
CARMEX DAILY CARE MOISTURIZING LIP BALM WINTERGREEN SPF 15 
octinoxate, oxybenzone salve
Product Information
Item Code (Source)NDC:10210-0033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CERESIN (UNII: Q1LS2UJO3A)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0033-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/20/2018
Part 2 of 2
CARMEX CLASSIC LIP BALM MEDICATED 
camphor (synthetic), white petrolatum salve
Product Information
Item Code (Source)NDC:10210-0038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)17 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM453 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
MINERAL OIL (UNII: T5L8T28FGP)  
MENTHOL (UNII: L7T10EIP3A)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
PHENOL (UNII: 339NCG44TV)  
VANILLIN (UNII: CHI530446X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0038-010 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/20/2018
Labeler - Carma Laboratories, Inc. (006090153)

Revised: 12/2023
Document Id: 0c054552-a2c8-d30b-e063-6294a90ac293
Set id: bc0162bc-92ca-ee78-e053-2a95a90a7c9d
Version: 3
Effective Time: 20231208
 
Carma Laboratories, Inc.