Active Ingredients
Octinoxate 7.5%
Zinc Oxide 6.0%
Lip Balm Spf
FDA Label NDC 70533-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harry's, Inc. for the product Lip Balm Spf (NDC 70533-002). 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 active ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging.
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 or irritation occurs
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• apply liberally 15 minutes before sun exposure • re-apply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • children under 6 months: ask a doctor
Inactive Ingredients
Hydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Beeswax, C12-15 Alkyl Benzoate, C18-C70 Isoparaffin, Myristyl Myristate, Polyethylene, Flavor, Paraffin, Menthyl Lactate, Tocopheryl Acetate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Triethoxycaprylylsilane, Limonene, BHT, Linalool, Cucumis Sativus (Cucumber) Seed Extract, Citric Acid
Other Information
Protect the product in this container from excessive heat and direct sun
Questions Or Comments?
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