Skin Strong - Skin Equipment
FDA Label NDC 51401-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by True Balance Athletics Llc for the product Skin Strong - Skin Equipment (NDC 51401-030). 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 - when using, otc - stop use, directions, sun alert, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

AVOBENZONE 3.00%, HOMOSALATE 7.5%, OCTISALATE 5.00%, OCTOCRYLENE 2.75%, OXYBENZONE 4.00%

Purpose

SUNSCREEN

Uses

  • HELPS PREVENT SUNBURN
  • HIGHER SPF GIVES MORE SUNBURN PROTECTION

Warnings:

FOR EXTERNAL USE ONLY

Otc - When Using

WHEN USING THIS PRODUCT:

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

Otc - Stop Use

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

Directions

  • APPLY LIBERALLY 20 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED
  • FOR CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR

Sun Alert

LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING AND USING SUNSCREEN REDUCES THE RISK OF AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN.

Ingredients

WATER, ADIPIC ACID/ DIETHYLENE DIGLYCOL GLYCERIN CROSSPOLYMER, C 12-15 ALKYL BENZOATE, ALOE BARBADENSIS LEAF EXTRACT, RETINYL PALMITATE, TOCOPHERYL ACETATE SODIUM ASCORBYL PHOSPHATE, STEARETH-21, TRIETHANOLAMINE, PROPYLENE GLYCOL, DECYL GLUCOSIDE, SORBITAN STEARATE, STEARETH-2, ACRYLATES/ C 10-30 ALKYL ACETATE CROSSPOLYMER, DIAZOLIDINYL UREA, METHYLPARABEN, CARBOMER, HYDROXYPROPYL, METHYLCELLULOSE, DISODIUM EDTA, PROPYLPARABEN

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