Help Me
FDA Label NDC 50184-1000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Philosophy Inc. for the product Help Me (NDC 50184-1000). 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 - Active Ingredient

Avobenzone 2.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 1.5%

Oxybenzone 4.0%

Otc - Purpose

Avobenzone: Sunscreen

Homosalate: Sunscreen

Octisalate: Sunscreen

Octocrylene: Sunscreen

Oxybenzone: Sunscreen

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • 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. If sensitive to retinol, use once every 2-3 days build to a daily use as tolerated.

When using this product keep out of eyes, rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Dosage & Administration

  • apply liberally 15 minutes before sun exposure on clean dry skin, avoiding the eye area
  • reapply at least every 2 hours when using as a sunscreen
  • 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 or higher and other sun protection measures including:
    •                                  
                                   limit time int he sun, especially from 10 a.m.-2 p.m.
                                   wear long sleeve shirts, pants, hats and sunglasses
                                   ask a doctor. this product should NOT be used on children of any age.

Inactive Ingredient

water, c12-15 alkyl benzoate, butylene glycol, glycerin, potassium cetyl phosphate, methyl methacrylate/glycol dimethacrylate crosspolymer, arachidyl alcohol, dimethicone, glyceryl myristate, peg-100 stearate, sodium hyaluronate, retinol, picea abies wood extract, ethylhexylglycerin, tocopheryl acetate, dipotassium glycyrrhizate, arachidyl glucoside, bentonite, allyl methacrylates crosspolymer, acrylates/c10-30 alkyl acrylate crosspolymer, behenyl alcohol, sodium hydroxide, disodium edta, bht, erythorbic acid, polysorbate 20, chlorphenesin, titanium dioxide, phenoxyethanol.

Package Label.Principal Display Panel

Helpme_outer (Helpme Outer)

Helpme_outer (Helpme Outer)

Helpme_inner (Helpme Inner)

Helpme_inner (Helpme Inner)

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