Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen Spf 15 Kit
FDA Label NDC 10210-0059

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carma Laboratories, Inc. for the product Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen Spf 15 (NDC 10210-0059). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

White Petrolatum 35.00%

Octinoxate 7.50%

Oxybenzone 4.00%

Purpose

Sunscreen

Lip Protectant

Sunscreen

Uses

  • helps protect against sunburn and chapped lips
  • higher SPF gives more sunburn protection
    • 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

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, notskin cancer or early skin aging.

For external use only

Do Not Use

on damaged or broken skin

on damaged or broken skin

When Using This Product:

keep out of eyes. Rinse with water to remove.

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If:

rash occurs

rash occurs

Keep Out Of Reach Of Children.

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

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

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 personal care item, and should be used by one individual only

• protect this product from excessive heat and direct sun

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

• 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

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

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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