Carmex 10 Count Variety Pack Spf 15 Sunscreen Kit
FDA Label NDC 10210-0057
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 10 Count Variety Pack Spf 15 Sunscreen (NDC 10210-0057). 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
Active Ingredients
Octinoxate 7.50%
Oxybenzone 4.00%
Octinoxate 7.50%
Oxybenzone 4.00%
White Petrolatum 35.00%
Purpose
Sunscreen
Sunscreen
Lip Protectant
Uses
- helps protect against sunburn
- higher SPF gives more sunburn protection
- helps protect against sunburn and chapped lips
- 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, notskin 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: • 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
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
• 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
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 (Label)
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