Mania Holic Sunscreen Pack Cream
FDA Label NDC 83888-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Firstmarket Co., Ltd. for the product Mania Holic Sunscreen Pack (NDC 83888-001). 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 dosage & administration, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Dosage & Administration

Apply liberally 15 minutes before sun exposure. avoid excessive rubbing during application, as it may result in clumping or uneven texture, for makeup application, allow it to completely dry for one minute, best results when applied over base makeup.
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 a broad spectrum SPF of 15 of higher and other sun protection measures including: Limited time in the sun, especially from 10 am to 2 pm, Wear long-sleeve shirts, pants, hats, and sunglasses. reapply at least every 2 hours, use a water-resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor

Otc - Active Ingredient

Octocrylene 9%

Homosalate 7.2%

Octisalate 4.8%

Avobenzone 2.8%

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburn

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.

Stop using and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Cellulose, Butyloctyl Salicylate, Silica, Dipropylene Glycol, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Benzyl Glycol, Polysorbate 80, Glyceryl Stearate, Polymethylsilsesquioxane, PEG-100 Stearate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Poly C10-30 Alkyl Acrylate, Xanthan Gum, Ethylhexylglycerin, Adenosine, 1,2-Hexanediol, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Fragrance

Other Safety Information

Store away from direct sunlight.

Keep the lid closed when not in use.

* Please review the disclaimer below.