Mally Lip Defender
FDA Label NDC 76119-5306

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mallygirl, Llc for the product Mally Lip Defender (NDC 76119-5306). 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, use, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 2.0%

Octinoxate 7.0%

Purpose

Sunscreen

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

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask doctor if rash occurs.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: ask a doctor.
  • Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including:
  • Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Polybutene, Helianthus annuus (sunflower) seed oil, Polyglyceryl-2  triisostearate, Octyldecanol, Euphorbia cerifera (candelilla) wax (candelilla cera), Trihydroxystearin, Copernicia cerifera (carnauba) wax (cera carnauba),  Microcrystalline wax (microcristallina cera), Phospholipids, Calcium aluminum borosilicate, Calcium sodium borosilicate, Tocopheryl acetate, Silica, Sodium chondroitin sulfate, Saccharomyces cerevisiae extract, Hyaluronic acid, Tocopherol, Alumina, Tripeptide-29, Tin oxide, Titanium dioxide (CI 77891) May Contain: Mica (CI 77019), Red 28 Lake (CI 45410), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Red 7 Lake (CI 15850), Yellow 6 Lake (CI 15985), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

Other Information

  • Protect this product from excessive heat and direct sun.

Principal Display Panel

mally

Lip Defender
Encouraging Peach
duos with sunscreen
Broad Spectrum SPF 15
Tube Label (Lip Defender Spf Labelpeach 01)

Tube Label (Lip Defender Spf Labelpeach 01)

Drug Facts Label Carton (Lip Defender Lipglosspeach 01)

Drug Facts Label Carton (Lip Defender Lipglosspeach 01)



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