Eight Hour Cream Targeted Sun Defense Spf 50
FDA Label NDC 67938-1130

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 Targeted Sun Defense Spf 50 (NDC 67938-1130). 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.

Label Section Quick Index

Description

Target over-exposed areas such as lips, nose, earlobes, even scars to shield from the burning and aging effects of UVA and UVB rays. Eight Hour Cream hydrating benefits sooth and smooth for up to 8 hours.

Oil-free. Water-resistant. PABA-free. Non-acnegenic. Perspiration-resistant. Suitable for all skin types. Ophthalmologist, clinically and dermatologist tested.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 40 minutes of swimming or perspiring.

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.

Indications And Usage

Directions: Apply liberally and evenly to targeted areas 30 minutes before sun exposure and as needed. Reapply after 40 minutes of swimming or perspiring, and after towel drying. Otherwise, reapply at least every 2 hours. Children under 6 months of age: ask a doctor.

Warnings

Warnings: For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a poison controll center right away.

Otc - Active Ingredient

Active Ingredients: Homosalate 7.5% w/w, Octinoxate 7.5% w/w, Octocrylene 5.0% w/w, Oxybenzone 4.0% w/w, Avobenzone 2.0% w/w.

Inactive Ingredient

Other Ingredients: Octyldodecyl Myristate, Polyethylene, Phenyl Trimethicone, Tocopheryl Acetate, Caprylyl Glycol, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Phenoxyethanol.

Dosage & Administration

Apply evenly and liberally to targeted areas.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Helps prevent sunburn. Higher SPF gives more sun protection.

Otc - When Using

Keep out of eyes.

* Please review the disclaimer below.