Otc - Active Ingredient
Active ingredients Purpose
OCTINOXATE 7.5% Sunscreen
OCTISALATE 5.0% Sunscreen
Lip Conditioner Spf 15 Jelly
FDA Label NDC 57627-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Merle Norman Cosmetics, Inc for the product Lip Conditioner Spf 15 (NDC 57627-107). 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
Uses
· helps prevent sunburn
Otc - Keep Out Of Reach Of Children
· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.
Indications & Usage
· Stop use and ask a doctor if rash occurs and persists
Warnings
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.
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.
Dosage & Administration
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
Inactive Ingredient
Inactive
Ricinus communis ( castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera ( candelilla) wax, copernicia cerifera ( carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea ) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411
Package Label.Principal Display Panel
Lip Conditioner
SPF 15
Merle Norman
3.7 g net. wt. .13 oz.
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