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

Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted by

Drug Labeling and Warnings

Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted 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%

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, polyamide8 ,polyhydroxystearic acds, stevia rebaudiana extract. Wintergreen:

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

Uses

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

Warnings

Skin Cancer/Skin Aging Alert: 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.

For external use only

Do not use

Skin Cancer/Skin Aging Alert: 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.

For external use only

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, polyamide8 ,polyhydroxystearic acid, stevia rebaudiana extract. Fresh Cherry,Strawberry:

Package labeling:

Package Labeling:10210-0029-1

Package Labeling: 10210-0032-1

Package Labeling: 10210-0033-2

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0042

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0042-1	1 in 1 KIT	01/31/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 g
Part 2	2 TUBE	20 g
Part 3	1 TUBE	10 g

Part 1 of 3

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

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)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0029-1	10 g in 1 TUBE; 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	05/20/2019

Part 2 of 3

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0032-1	10 g in 1 TUBE; 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	07/12/2017

Part 3 of 3

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

Product Information
Item Code (Source)	NDC: 10210-0037
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
ISOHEXADECANE (UNII: 918X1OUF1E)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0037-1	10 g in 1 TUBE; 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	03/31/2020

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

Labeler - Carma Laboratories, Inc. (006090153)