Premium Sunscreen
FDA Label NDC 71585-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salt And Stone for the product Premium Sunscreen (NDC 71585-102). 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 - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

ZINC OXIDE 10%

OCTINOXATE 7%

Purpose

SUNSCREEN

Uses

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DESCREASES THE RISK OF SKIN CANCER AND EARLY 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.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

    • REAPPLY:

    • AFTER 80 MINUTES OF SWIMMING OR SWEATING
    • IMMEDIATELY AFTER TOWEL DRYING
    • AT LEAST EVERY 2 HOURS

      • 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 SUN SCREEN WITH A BROAD SPECTRUM OF SPF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

      • LIMIT TIME IN THE SUN, FROM 10 A.M. - 2 P.M.
      • WEAR LONG-SLEEVE SHIRTS, PANTS, HATS, AND SUNGLASSES
      • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR

Inactive Ingredients

* ALOE BARBADENSIS JUICE, * COCOS NUCIFERA (COCONUT) OIL, * HELIANTHUS ANNUUS (SUNFLOWER) OIL, GLYCERYL STEARATE, * THEOBROMA CACAO (COCOA) BUTTER, * VITELLARIA PARADOX (SHEA) BUTTER, STEARIC ACID, CETEARYL ALCOHOL, SODIUM STEARYL LACTATE, * SIMMONDSIA CHINENSIS (JOJOBA) OIL, * CERA ALBA (BEESWAX), * VANILLA, PHENOXYETHANOL, XANTHAN GUM, * TOCOPHEROL (VITAMIN E), SODIUM CITRATE, HYDROXYETHYLCELLULOSE, CITRIC ACID

* CERTIFIED ORGANIC

Other Information

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

Questions Or Comments?

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