CARMEX 10 COUNT VARIETY PACK SPF 15 SUNSCREEN- octinoxate, oxybenzone, petrolatum 
Carma Laboratories, Inc.

----------

Carmex 10 Count Variety Pack SPF 15 Sunscreen( 3 Strawberry+ 2 Fresh Cherry+ 2 Wintergreen+ 3 Classic)

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

Uses

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

Other Information

• protect this product from excessive heat and direct sun

Inactive Ingredients

Fresh Cherry, Strawberry

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

Wintergreen

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

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

White Petrolatum 35.00%

Purpose

Sunscreen

Lip Protectant

Uses

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: • at least every 2 hours

• children under 2 years of age: ask a doctor

Other Information

• protect this product from excessive heat and direct sun

Inactive Ingredients

lanolin, theobroma cacao seed butter, euphorbia cerifera wax, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

Package Labeling:

Label

CARMEX 10 COUNT VARIETY PACK SPF 15 SUNSCREEN 
octinoxate, oxybenzone, petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0057
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0057-11 in 1 TRAY01/01/2023
11 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 CYLINDER 12.75 g
Part 22 CYLINDER 8.5 g
Part 32 CYLINDER 8.5 g
Part 43 CYLINDER 12.75 g
Part 1 of 4
CARMEX DAILY CARE MOISTURIZING LIP BALM STRAWBERRY SPF 15 
octinoxate, oxybenzone salve
Product Information
Item Code (Source)NDC:10210-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0031-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2023
Part 2 of 4
CARMEX DAILY CARE MOISTURIZING LIP BALM FRESH CHERRY SPF 15 
octinoxate, oxybenzone salve
Product Information
Item Code (Source)NDC:10210-0028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0028-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2023
Part 3 of 4
CARMEX DAILY CARE MOISTURIZING LIP BALM WINTERGREEN SPF 15 
octinoxate, oxybenzone salve
Product Information
Item Code (Source)NDC:10210-0033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0033-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2023
Part 4 of 4
CARMEX CLASSIC LIP BALM MEDICATED SPF 15 
octinoxate, oxybenzone, petrolatum salve
Product Information
Item Code (Source)NDC:10210-0023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM35 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
PHENOL (UNII: 339NCG44TV)  
VANILLIN (UNII: CHI530446X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0023-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2023
Labeler - Carma Laboratories, Inc. (006090153)

Revised: 10/2023
Document Id: 088814d3-a2e3-3f58-e063-6294a90a14d3
Set id: bacc60ec-0b6a-4ba2-b246-a59694f06b77
Version: 3
Effective Time: 20231025
 
Carma Laboratories, Inc.