Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

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, 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: 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, beeswax, cetyl esters, flavor, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide 8, polyhydroxystearic acid, stevia rebaudiana extract

Package Labeling:

Kit Kit2

Package Labeling:10210-0029-0

Label4

Package Labeling:10210-0032-0

Label10

Package Labeling:10210-0034-0

label16

Package Labeling:10210-0035-0

label17

Package Labeling:10210-0036-0

label18

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10210-0040

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0040-1	1 in 1 KIT	11/05/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	5 g
Part 2	1 TUBE	5 g
Part 3	1 TUBE	5 g
Part 4	1 TUBE	5 g
Part 5	1 TUBE	5 g

Part 1 of 5

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

Product Information
Item Code (Source)	NDC:10210-0029
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
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0029-0	5 g in 1 TUBE; 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	05/20/2019

Part 2 of 5

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

Product Information
Item Code (Source)	NDC:10210-0032
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
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0032-0	5 g in 1 TUBE; 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	07/12/2017

Part 3 of 5

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

Product Information
Item Code (Source)	NDC:10210-0034
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
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0034-0	5 g in 1 TUBE; 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	11/05/2020

Part 4 of 5

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

Product Information
Item Code (Source)	NDC:10210-0035
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
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0035-0	5 g in 1 TUBE; 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	11/05/2020

Part 5 of 5

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

Product Information
Item Code (Source)	NDC:10210-0036
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)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)
YELLOW WAX (UNII: 2ZA36H0S2V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0036-0	5 g in 1 TUBE; 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	11/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/05/2020

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Daily Care Moisturizing Lip Balm SPF 15 Minis, Kit