Active Ingredients
Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Sun Shades Lip Balm Stick
FDA Label NDC 54473-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca Inc. for the product Sun Shades Lip Balm (NDC 54473-220). 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, uses, warnings, otc - do not use, otc - when using, 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
Purpose
Sunscreen
Uses
■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a dcotor if rash occurs
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 liberally 15 minutes before sun exposure
■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: ask a doctor
■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.-2 p.m.■ wear long-sleeve shirts, pants, hats, and sunglasses
Other Information
■ dermatologist and allergy tested
Storage And Handling
■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
Inactive Ingredients
ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, ethylene/VA copolymer, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)
Package Label.Principal Display Panel
Sun Shades Mountain Mint (504020107 Sunshadesmountainmint 0317 O)
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