Skindog
FDA Label NDC 42657-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skindog, Llc for the product Skindog (NDC 42657-111). 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 package label.principal display panel, uses, warnings, directions, inactive ingredients, otc - when using, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

Active Ingredients:                                                                                                   PurposeAvobenzone 3.0%...................................................................................................Sunscreen (A)Octocrylene  4.0%...................................................................................................Sunscreen (B)Oxybenzone 6.0%...................................................................................................Suncreeen (A)Homosalate  15.0%.................................................................................................Sunscreen (B)Octisalate     5.0%...................................................................................................Sunscreen (B)

Uses

  • High UVB sunburn/UVA protection
  • for skin highly sensitive to sunburn
  • retains SPF after 80 minutes of activity

Warnings

For External use onlyUV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

Directions

  • Apply liberally before sun exposure.
  • Apply and reapply as directed to avoid lowering protection.
  • Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every 2 hours.
  • Children under 6 months; ask a doctor.

Inactive Ingredients

Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone;  Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Tetrasodium EDTA; Tocopheryl Acetate

Otc - When Using

When using this product keep out of eyes.

Rinse with water to remove.

May stain some fabrics

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.

Otc - Ask Doctor

Stop use and ask a doctor if skin rash occurs.

* Please review the disclaimer below.