Eight Hour Cream Lip Protectant Spf 15
FDA Label NDC 67938-0774

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elizabeth Arden, Inc for the product Eight Hour Cream Lip Protectant Spf 15 (NDC 67938-0774). 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 description, indications and usage, warnings, otc - active ingredient, inactive ingredient, dosage & administration, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Description

An all weather treatment stick for softer, smoother lips. Sunscreen ingredients (SPF 15) guard against the damaging effects of sun exposure. Dermatologist, clinically and allergy tested.

Indications And Usage

Apply to lips.

Warnings

Warnings: Discontinue use if signs of irritation or rash appear and see a doctor. Keep out of reach of children.

Otc - Active Ingredient

Active Ingredients: Petrolatum 30.2% w/w, Padimate O 8.0% w/w, Oxybenzone 3.0% w/w.

Inactive Ingredient

Other Ingredients: Ricinus Communis (Castor) Seed Oil, Ozokerite, Glyceryl Rosinate, Cetyl Lactate, Myristyl Lactate, Lanolin Oil, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huille Vegetale, Zea Mays (Corn) Oil, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben, Iron Oxides.

Dosage & Administration

Apply to lips.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Protects skin. Provides SPF 15 sun protection.

Otc - When Using

Discontinue use if signs of irritation or rash appear.

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