Carmex Variety Pack - Classic Medicated Lip Balm, Daily Care Lip Balm Spf

Carmex Variety Pack - Classic Medicated Lip Balm, Daily Care Lip Balm Spf
SPL v1
SPL
SPL Set ID 5f904369-5f21-4907-98de-df23bce30823
Route
TOPICAL
Published
Effective Date 2025-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (1.7 g) White Petrolatum (45.3 g) Ethylhexyl Methoxycinnamate (75 mg) Benzophenone-3 (40 mg) Avobenzone (30 mg) Homosalate (100 mg) Ethylhexyl Salicylate (50 mg) Octocrylene (90 mg)
Inactive Ingredients
Lanolin Yellow Wax Cetyl Esters Wax Mineral Oil Menthol, Unspecified Form Salicylic Acid Phenol Vanillin Petrolatum Isopropyl Palmitate Paraffin Meadowfoam Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Camphor 1.70% White Petrolatum 45.30%

Purpose

External Analgesic Lip Protectant


Medication Information

Purpose

External Analgesic

Lip Protectant

Description

Camphor 1.70% White Petrolatum 45.30%

Uses
  • helps provide relief of symptoms of cold sores and dry lips
Warnings

For external use only

Directions

• apply to lips not more than 3 to 4 times daily

• children under 2 years of age: ask a doctor 

Do Not Use
  • deep puncture wounds 
  • serious burns
  • animal bites
Drug Facts

Do Not Use 

on damaged or broken skin

Other Information

• this is a personal care item, and should be used by one individual only

Package Labeling:

Active Ingredients

Avobenzone (3.0%)

Homosalate (10.0%)

Octisalate (5.0%)

Octocrylene (9.0%)

White Petrolatum (31.0%)

Active Ingredients

Camphor 1.70%

White Petrolatum 45.30%

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

Inactive Ingredients 

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

When Using This Product:

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If:
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If: 

rash occurs


Structured Label Content

Uses
  • helps provide relief of symptoms of cold sores and dry lips
Purpose

External Analgesic

Lip Protectant

Warnings

For external use only

Directions

• apply to lips not more than 3 to 4 times daily

• children under 2 years of age: ask a doctor 

Do Not Use (Do not use)
  • deep puncture wounds 
  • serious burns
  • animal bites
Drug Facts

Do Not Use  (Do not use )

on damaged or broken skin

Other Information (Other information)

• this is a personal care item, and should be used by one individual only

Package Labeling:

Active Ingredients

Avobenzone (3.0%)

Homosalate (10.0%)

Octisalate (5.0%)

Octocrylene (9.0%)

White Petrolatum (31.0%)

Active Ingredients (Active ingredients)

Camphor 1.70%

White Petrolatum 45.30%

Inactive Ingredients (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

Inactive Ingredients  (Inactive ingredients )

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

When Using This Product: (When using this product:)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If:  (Stop use and ask a doctor if: )

rash occurs


Advanced Ingredient Data


Raw Label Data

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