CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (camphor- synthetic, white petrolatum, octinoxate, oxybenzone kit

Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 by

Drug Labeling and Warnings

Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Carma Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Camphor 1.70%

White Petrolatum 45.30%

Purpose

External Analgesic

Lip Protectant

Uses

• helps provide relief of symptoms of cold sores and dry lips

Warnings

For external use only

When using this product:

keep out of eyes. Rinse with water to remove.

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

• 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 

Other information

this is a personal care item, and should be used by one individual only

Inactive ingredients 

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

Drug Facts

Active ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

White Petrolatum 35.00%

Purpose

Sunscreen

Lip Protectant

Uses

• helps protect against sunburn and chapped lips
• 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.

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

children under 2 years of age: ask a doctor

Other information

this is a personal care item, and should be used by one individual only

protect this product from excessive heat and direct sun

do not use if safety seal is broken prior to purchase

Inactive ingredients

lanolin, theobroma cacao seed butter, euphorbia cerifera cera, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

Package Labeling:

INGREDIENTS AND APPEARANCE

CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 
camphor (synthetic), white petrolatum, octinoxate, oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0088

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0088-1	1 in 1 KIT	04/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	7 TUBE	70 g
Part 2	2 CYLINDER	8.5 g

Part 1 of 2

CARMEX CLASSIC LIP BALM MEDICATED 
camphor (synthetic), petrolatum salve

Product Information
Item Code (Source)	NDC: 10210-0022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.7 g  in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	45.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
MINERAL OIL (UNII: T5L8T28FGP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PHENOL (UNII: 339NCG44TV)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0022-6	10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2025

Part 2 of 2

CARMEX CLASSIC LIP BALM MEDICATED SPF 15 
octinoxate, oxybenzone, petrolatum salve

Product Information
Item Code (Source)	NDC: 10210-0023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (BENZOPHENONE-3 - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	35 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PHENOL (UNII: 339NCG44TV)
VANILLIN (UNII: CHI530446X)
COCOA BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0023-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2025

Labeler - Carma Laboratories, Inc. (006090153)

Establishment
Name	Address	ID/FEI	Business Operations
Carma Laboratories, Inc.		006090153	manufacture(10210-0088, 10210-0022, 10210-0023)