Klenskin Spf Lip Balm Broad Spectrum
FDA Label NDC 61369-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colabs Intl. Corp for the product Klenskin Spf Lip Balm Broad Spectrum (NDC 61369-301). 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 active ingredients, purpose, uses, warnings, otc - keep out of reach of children, otc - stop use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 2.3%

Homosalate 9.2%

Octisalate 4.3%

Purpose

SUNSCREEN

Uses

  • Helps prevent sunburn
  • If used as directed with othersun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sun.

Warnings

  • For external use only
  • Do not use ondamaged or broken skin. When using this product, keepout of eyes and rinse with excessive water to remove.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.

Directions

Apply liberally 15 minutes before sun exposure

  • Reapply: • At least every 2 hours

Other Information

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 in the sun, especially from 10a.m.-2p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor.

• Protect this product from excessive heat & direct sunlight.

Inactive Ingredients

Cera Alba (Beeswax), Caprylic/Capric Triglyceride, Water, Polyethylene, Theobroma Cacao (Cocoa) Seed Butter, Bis-PEG-18 Methyl Ether Dimethyl Silane, Flavor, Butyrospermum parkii (Shea) Butter, Sorbitan Stearate, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Octyldecanol, Trimethoxybenzylidene Pentanedione, Stevia Rebaudiana Leaf Extact, Sodium Saccharin, Tocopheryl Acetate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chitosan, Algin, Phenoxyethanol, Ethylhexylglycerin

Questions Or Comments?

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Klenskin_2_1875x3_9688_cherry (Klenskin 2 1875x3 9688 Cherry)

Klenskin_2_1875x3_9688_cherry (Klenskin 2 1875x3 9688 Cherry)

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