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

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

Drug Labeling and Warnings

Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen 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

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:

INGREDIENTS AND APPEARANCE

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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)

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	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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0030-1	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	01/01/2023

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

Labeler - Carma Laboratories, Inc. (006090153)