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

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. Skin Cancer/Skin Aging Alert:

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

• protect this product from excessive heat and direct sun

Inactive Ingredients

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

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

Uses

helps protect against sunburn
higher SPF gives more sunburn protection

Warnings

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, skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:not

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: • 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

Other Information

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

• protect this product from excessive heat and direct sun

Inactive Ingredients

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

Package Labeling:

Label3

CARMEX CLASSIC LIP BALM MEDICATED FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15
octinoxate, oxybenzone, white petrolatum kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10210-0059

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10210-0059-1	1 in 1 BLISTER PACK	01/01/2023
1		1 in 1 KIT

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	3 CYLINDER	12.75 g
Part 2	1 CYLINDER	4.25 g

Part 1 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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/01/2023

Part 2 of 2

CARMEX DAILY CARE MOISTURIZING LIP BALM CUPCAKE BATTER SPF 15
octinoxate, oxybenzone salve

Product Information
Item Code (Source)	NDC:10210-0030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0030-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/01/2023

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15

Drug Facts

Active Ingredients

Purpose

Uses

Warnings

Do not use

When using this product:

Stop use and ask a doctor if:

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

Drug Facts

Active Ingredients

Purpose

Uses

Warnings

Do not use

When using this product:

Stop use and ask a doctor if:

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

Package Labeling: