Zinc Five-o Zinxation Baby Mineral Sunscreen
FDA Label NDC 80982-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astivita Limited for the product Zinc Five-o Zinxation Baby Mineral Sunscreen (NDC 80982-005). 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, directions:, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

ZINC OXIDE 25%

Purpose

SUNSCREEN

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin 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.

Directions:

  • APPLY LIBERALLY AND EVENLY 20 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY:
  •    AFTER 40 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 SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
    •    LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
    •    WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
    • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Other Information

STORE AT TEMPERATURES BELOW 90°F (30°C). PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients

Water, Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, Aloe Barbadensis Leaf Extract, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

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