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, 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: • 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 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

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

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

Uses

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

Warnings

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

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

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:10210-0049-1

Kit

Package Labeling:10210-0050-1

Label

Package Labeling:10210-0051-1

label4

Package Labeling:10210-0052-1

Label2

Package Labeling:10210-0033-1

Label3

CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15
octinoxate, oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10210-0049

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0049-1	1 in 1 KIT	01/31/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CYLINDER	4.25 g
Part 2	1 CYLINDER	4.25 g
Part 3	1 CYLINDER	4.25 g
Part 4	1 CYLINDER	4.25 g

Part 1 of 4

CARMEX DAILY CARE MOISTURIZING LIP BALM MERRY BERRY SPF 15
octinoxate, oxybenzone salve

Product Information
Item Code (Source)	NDC:10210-0050
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)
CERESIN (UNII: Q1LS2UJO3A)
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:10210-0050-1	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	01/31/2019

Part 2 of 4

CARMEX DAILY CARE MOISTURIZING LIP BALM SUGAR PLUM SPF 15
octinoxate, oxybenzone salve

Product Information
Item Code (Source)	NDC:10210-0051
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)
CERESIN (UNII: Q1LS2UJO3A)
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:10210-0051-1	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	01/31/2019

Part 3 of 4

CARMEX DAILY CARE MOISTURIZING LIP BALM VANILLA ICING SPF 15
octinoxate, oxybenzone salve

Product Information
Item Code (Source)	NDC:10210-0052
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)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0052-1	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	01/31/2019

Part 4 of 4

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

Product Information
Item Code (Source)	NDC:10210-0033
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)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0033-1	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	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/31/2019

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15, 1 Merry Bery- 1 Sugar Plum- 1 Vanilla Icing - 1 Wintergreen, Kit

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:10210-0049-1

Package Labeling:10210-0050-1

Package Labeling:10210-0051-1

Package Labeling:10210-0052-1

Package Labeling:10210-0033-1