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

Carmex Daily Care Moisturizing Lip Balm SPF 15 by

Drug Labeling and Warnings

Carmex Daily Care Moisturizing Lip Balm 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%

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 

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

Strawberry Inactive ingredients 

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

Cupcake Batter Inactive ingredients

petrolatum, lanolin, euphorbia cerifera cera, 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 DAILY CARE MOISTURIZING LIP BALM SPF 15 
octinoxate, oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0091

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0091-1	1 in 1 KIT	04/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 CYLINDER	8.5 g
Part 2	1 CYLINDER	4.25 g

Part 1 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) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (BENZOPHENONE-3 - 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	04/01/2025

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 10210-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (BENZOPHENONE-3 - 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: 10210-0031-1	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	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2025

Labeler - Carma Laboratories, Inc. (006090153)

Establishment
Name	Address	ID/FEI	Business Operations
Carma Laboratories, Inc.		006090153	manufacture(10210-0030, 10210-0031, 10210-0091)