Flormar Lip Moisturizer Orange Sunscreen Broad Spectrum Spf 15
FDA Label NDC 61722-252

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kosan Kozmetik Sanayi Ve Ticaret A.s. for the product Flormar Lip Moisturizer Orange Sunscreen Broad Spectrum Spf 15 (NDC 61722-252). 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 ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Octinoxate 6.8%

Purpose

Sunscreen

Use

  • 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.

Stop Use And Ask A Doctor If

rash occurs

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply on the lips. Reapply when lips are exposed to strong sun for protection.
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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 value 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.

                      • Children under 6 months of age: Ask a doctor. 

Other Information

Protect this product in this container from excessive heat and direct sun

Inactive Ingredients

DIISOSTEARYL MALATE, TRIDECYL TRIMELLITATE, OCTYLDODECANOL, HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, POLYETHYLENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, TRIISOSTEARYL CITRATE, SILICA, MICROCRYSTALLINE WAX, MICA, CANDELILLA (EUPHORBIA CERIFERA) WAX, ZINC OXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYMETHYL METHACRYLATE, PENTAERTHRITYL TETRABEHENATE, POLYBUTENE, SHEA (BUTYROSPERMUM PARKII) BUTTER, COCOA (THEOBROMA COCAO) SEED BUTTER, CASTOR (RICINUS COMMUNIS) SEED OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, FLAVOR, PEG-8, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANDIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, TITANIUM DIOXIDE, D&C RED NO. 6., FD&C YELLOW NO.5 ALUMINUM LAKE.

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