CARMEX DAILY CARE MOISTURIZING LIP BALM SPF15 BROAD SPRECTRUM MINIS- homosalate, octocrylene, octisalate, avobenzone kit

Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis by

Drug Labeling and Warnings

Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis 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

Homosalate (7.0%)

Octocrylene (5.3%)

Octisalate (3.3%)

Avobenzone (2.4%)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• provides moderate protection against sunburn 
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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 Posion Control Center right away.

Directions

apply generously and evenly 15 minutes before sun exposure
children under 6 months: Ask a doctor reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses

Inactve ingredients

Strawberry, Fresh Cherry, Wild Berry & Peach Mango 
petrolatum, lanolin, beeswax, cetyl esters, flavor, theobroma cacao (cocoa) seed butter, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, polypropylene, isohexadecane, polyamide-8, polyhydroxystearic acid, stevia rebaudiana extract

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

Package Labeling:

Package Labeling:FRESH CHERRY

Package Labeling:STRAWBERRY

Package Labeling:COOL MINT

Package Labeling:PEACH MANGO

Package Labeling:WILD BERRY

INGREDIENTS AND APPEARANCE

CARMEX DAILY CARE MOISTURIZING LIP BALM SPF15 BROAD SPRECTRUM MINIS 
homosalate, octocrylene, octisalate, avobenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0067

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0067-1	1 in 1 TRAY	01/01/2023
1		1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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 SPF 15 FRESH CHERRY 
homosalate, octocrylene, octisalate, avobenzone salve

Product Information
Item Code (Source)	NDC: 10210-0068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	53 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	33 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0068-1	5 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	01/01/2023

Part 2 of 5

CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 STRAWBERRY 
homosalate, octocrylene, octisalate, avobenzone salve

Product Information
Item Code (Source)	NDC: 10210-0069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	53 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	33 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0069-1	5 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	01/01/2023

Part 3 of 5

CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 COOL MINT 
homosalate, octocrylene, octisalate, avobenzone salve

Product Information
Item Code (Source)	NDC: 10210-0070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	53 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	33 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0070-1	5 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	01/01/2023

Part 4 of 5

CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 PEACH MANGO 
homosalate, octocrylene, octisalate, avobenzone salve

Product Information
Item Code (Source)	NDC: 10210-0071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	53 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	33 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0071-1	5 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	01/01/2023

Part 5 of 5

CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 WILD BERRY 
homosalate, octocrylene, octisalate, avobenzone salve

Product Information
Item Code (Source)	NDC: 10210-0072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	53 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	33 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0072-1	5 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	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023

Labeler - Carma Laboratories, Inc. (006090153)