Reverse It Kit
FDA Label NDC 49520-503

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mybody for the product Reverse It Kit (NDC 49520-503). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

TITANIUM DIOXIDE 10.9%

ZINC OXIDE 4.01%

Otc - Purpose

PURPOSE

SUNSCREEN

Indications & Usage

USE HELPS PROTECT AGAINST SUNBURN

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - When Using

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

Otc - Stop Use

  • 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.

Otc - Do Not Use

DO NOT USE

  • ON INFLAMED OR BROKEN SKIN.

Dosage & Administration

DIRECTIONS

USE AM. APPLY AS NEEDED TO FACE AND NECK AREA. CAN ALSO BE APPLIED TO THE EARS, HANDS AND DECOLETAGE. APPLY EVENLY 15-30 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED. REAPPLY AS NEEDED OR AFTER SWIMMING OR PERSPIRING. FOR BEST RESULTS

  • CLEANSE SKIN THOROUGHLY BEFORE APPLYING.
  • APPLY LIBERALLY TO FACE AND NECK BEFORE SUN EXPOSURE.
  • USE ALONE OR UNDER MAKE-UP.
  • CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.

Other Safety Information

OTHER INFORMATION

  • STORE AT ROOM TEMPERATURE
  • AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.
  • DO NOT USE IF INNER SEAL IS BROKEN.

    • SUN ALERT

    LIMITING SUN EXPOSURE, WEARING PRODUCTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN.

Inactive Ingredient

INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, CYCLOMETHICONE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, SORBITAN ISOSTEARATE, TRIBEHENIN, CALCIUM BEHENATE, MELANIN, DIMETHICONOL, ALUMINA, PEG-10 DIMETHICONE, METHICONE, IRON OXIDES, CHOLECALCIFEROL, LYCOPENE, GLYCERIN, SUCROSE PALMITATE, LECITHIN.

Package Label.Principal Display Panel

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