Skinsuit Lip Gel
FDA Label NDC 46007-205

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skin Authority Llc for the product Skinsuit Lip (NDC 46007-205). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, sun protection measures:, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

ZINC OXIDE 10%

Purpose

SUNSCREEN

Uses

  • HELPS PREVENT SUNBURN
  • IF USED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY SUN.

Warnings

FOR EXTERNAL USE ONLY.

DO NOT USE ON

  • BROKEN SKIN
  • SERIOUS BURNS

    • WHEN USING THIS PRODUCT

    • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

      • STOP USE AND ASK A DOCTOR IF

      • RASH OR IRRITATION DEVELOPS AND LASTS

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.

Sun Protection Measures:

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH BROAD SPECTRUM SPF VALUE OF 15+ AND OTHER SUN PROTECTION MEASURES

  • LIMIT TIME IN THE SUN FROM 10AM - 2PM
  • WEAR LONG SLEEVED SHIRT, PANTS, HATS, AND SUNGLASSES

Directions

APPLY EVENLY TO UPPER AND LOWER LIP 15 MINUTES BEFORE EXPOSURE. NATURAL TINT WILL ABSORB AND BECOME SHEER.

  • REAPPLY EVERY 2 HOURS
  • REAPPLY AS NEEDED AFTER SWIMMING OR PERSPIRING
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Inactive Ingredient

HYDROGENATED POLY(C6-14 OLEFIN), SQUALANE, BUTYLOCTYL SALICYLATE, CETEARYL DIMETHICONE, ISODODECANE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, CAPRYLYL METHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDE, LECITHIN, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, CAPRYLYL GLYCOL, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PHENYLPROPANOL, PROPANEDIOL, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), TOCOPHEROL.

Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN. STORE AT 40° - 95°F (5° - 35°C).

Questions?

1-866-325-7546

MONDAY - FRIDAY (9 A.M. TO 5 P.M. PST)

* Please review the disclaimer below.