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

Inactive Ingredients

Strawberry, Wild Berry & Peach Mango

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

petrolatum, lanolin, beeswax, cetyl esters, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide 8, polyhydroxystearic acid, stevia rebaudiana extract Cool Mint

Package Labeling:

Label04

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10210-0065

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10210-0065-1	1 in 1 TRAY	08/11/2021
1		1 in 1 KIT

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 1 of 4

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
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
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	08/11/2021

Part 2 of 4

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
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
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	08/11/2021

Part 3 of 4

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
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
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	08/11/2021

Part 4 of 4

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)
YELLOW WAX (UNII: 2ZA36H0S2V)
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:10210-0036-0	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	08/11/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/11/2021

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis, 1 Strawberry+ 1 Wild Berry+ 1 Cool Mint+ 1 Peach Mango