Carmex Daily Care Moisturizing Lip Balm Spf 15 Assorted Kit
FDA Label NDC 10210-0042
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 Daily Care Moisturizing Lip Balm Spf 15 Assorted (NDC 10210-0042). 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%
Purpose
Sunscreen
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, not skin cancer or early skin aging.
For external use only
Do Not Use
on damaged or broken skin
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
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: 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: ask a doctor
Other Information
• this is a personal care item, and should be used by one individual only
• protect this product from excessive heat and direct sun
• do not use if safety seal is broken prior to purchase
• this is a personal care item, and should be used by one individual only
• protect this product from excessive heat and direct sun
• do not use if safety seal is broken prior to purchase
Inactive Ingredients
Wintergreen:petrolatum, lanolin, beeswax,cetyl esters, flavor, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide8 ,polyhydroxystearic acds, stevia rebaudiana extract.
Inactive Ingredients:
Fresh Cherry,Strawberry: petrolatum, lanolin, beeswax,cetyl esters, flavor, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide8 ,polyhydroxystearic acid, stevia rebaudiana extract.
Package Labeling:
Card (Card)
Tray (Tray)
Package Labeling:10210-0029-1
Label4 (Label4)
Package Labeling: 10210-0032-1
Bottle11 (Bottle11)
Package Labeling: 10210-0033-2
Bottle15 (Bottle15)
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