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Drug Facts
Reef Safe Lip Balm Lipstick
FDA Label NDC 82953-049
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmuses Cosmetics (ningbo) Co., Ltd. for the product Reef Safe Lip Balm (NDC 82953-049). 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 other, active ingredients, purpose, uses, warnings, skin cancer/ skin aging alert, otc - stop use, otc - 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
Active Ingredients
Avobenzone 2%
Homosalate 5%
Octisalate 3%
Octocrylene 3%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- Helps prevent and temporarily protect dry, chapped or windblown lips.
Warnings
For external use only
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 prevent sunburn, not cancer or early aging.
Otc - Stop Use
Stop use and ask a doctor: if rash or irritation develops and persists.
Otc - 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.
Directions
Apply librerally before sun exposure and as needed.
Children under 6 months or age: ask a doctor before use.
Inactive Ingredients
Mineral Oil,Ozokerite, Petrolatum, Triethoxycaprylylsilane, Microcrystalline Wax, Beeswax, Tridecyl Trimellitate, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Tocopherol, Phenoxyethanol,Fragrance, BHT
Questions?
Tekweld 45 Rabro Dr.Hauppauge, NY 11788
www.tekweld.com
Package Label.Principal Display Panel
82953-049 (Cb222 Templatenew)
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