2pm Reset Mist Spf 50 Orange Slice Liquid
FDA Label NDC 88112-025

12 label sections · Submitted to the FDA by 2pm Brands Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 2pm Brands Llc for the product 2pm Reset Mist Spf 50 Orange Slice (NDC 88112-025). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Avobenzone (3.0%)
Octisalate (5.0%)
Octocrylene (10%)

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

Do Not Use

• on damaged or broken skin.

When Using This Product

• keep out of eyes. Rinse with water to remove.

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 and as needed. • Children under 6 months of age: ask a doctor.
• Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying 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 the 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. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Alcohol, Butyloctyl Salicylate, Citrus Aurantium Dulcis (Orange) Peel Oil, Acrylates/Octylacrylamide Copolymer, Niacinamide, Squalane, Ascorbyl Palmitate, Tocopheryl Acetate, Cucumis Sativus (Cucumber) Fruit Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil.

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