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: as needed ot after towel drying, swimming or sweating

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 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

Wintergreen:petrolatum, lanolin, euphorbia cerifera (candelilla) wax, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

Fresh Cherry, Strawberry:petrolatum, lanolin, euphorbia cerifera (candelilla) wax, ozokerite, flavor, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

10210-0078-1

kit

Kit2

Package Labeling:FRESH CHERRY

FRESH CHERRY

Package Labeling:STRAWBERRY

STRAWBERRY

Package Labeling:WINTERGREEN

WINTERGREEN

CARMEX DAILY CARE MOISTURIZING LIP SPF 15 ASSORTED
homosalate, octocrylene, octisalate, avobenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10210-0078

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10210-0078-1	1 in 1 TRAY	01/01/2023
1		1 in 1 KIT

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CYLINDER	4.5 g
Part 2	2 CYLINDER	9 g
Part 3	1 CYLINDER	4.5 g

Part 1 of 3

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

Product Information
Item Code (Source)	NDC:10210-0079
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0079-1	4.5 g in 1 CYLINDER; 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	01/01/2023

Part 2 of 3

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

Product Information
Item Code (Source)	NDC:10210-0080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0080-1	4.5 g in 1 CYLINDER; 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	01/01/2023

Part 3 of 3

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

Product Information
Item Code (Source)	NDC:10210-0081
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10210-0081-1	4.5 g in 1 CYLINDER; 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	01/01/2023

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

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Daily Care Moisturizing Lip Balm SPF 15 STICK Assorted,1 Fresh Cherry + 2 Strawberry + 1 Wintergreen