Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3.0% Sunscreen
Ocinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Mint Fusion Lip Balm Spf 30
FDA Label NDC 75936-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd. for the product Mint Fusion Lip Balm Spf 30 (NDC 75936-113). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and/or lips. 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings 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. If swallowed, get medical help or contact a poison control center right away. If condition worsens or does not improve within 7 days, consult a doctor.
Dosage & Administration
Directions
· Apply liberally 15 minutes before sun exposure
-Reapply liberally as often as necessary
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months: Ask a doctor
Reapply at least every 2 hours
· 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 broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
Inactive Ingredient
Inactive Ingredients- Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) wax, Copernicia cerifera (carnauba) Wax, Polysiilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (coconut) Fruit Extract
Package Label.Principal Display Panel
Supergoop SPF 30
Soothe
Protect
Hydrate
MintFusion Lip Balm with Shea Butter
.50 Fl Oz
Primary (Box)
Secondary (Tube)
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