Sunscreen
FDA Label NDC 43239-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Erbaviva Inc. for the product Sunscreen (NDC 43239-101). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredientZINC OXIDE 20%

Otc - Purpose

PURPOSE

SUNSCREEN

Indications & Usage

  • HELPS PREVENT SUNBURN

Warnings

WARNINGS
  • FOR EXTERNAL USE ONLY

Otc - Do Not Use

  • DO NOT USE ON DAMAGED OR BROKEN SKIN.

Otc - When Using

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

Otc - 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.

Dosage & Administration

Directions• apply liberally 15 minutes before sun exposure.• use a water resistant sunscreen if swimming or sweating• reapply at least every 2 hours

Other Safety Information

  • 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 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-sleeve shirts, pants, hats, and sunglasses

Pediatric Use

  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Inactive Ingredient

Inactive ingredients: *Aloe barbadensis leaf juice, *anthemis nobilis (chamomile) flower oil, caprylic/capric triglycerides, *helianthus annuus (sunflower) seed oil, hydrogenated methyl abietate, *lavandula angustifolia (lavender) flower oil, magnesium sulfate, *olea europaea (olive) fruit oil, polyaminopropyl biguanide, polyglycerol-10 laurate, ricinus communis (castor) seed oil, *simmondsia chinensis (jojoba) seed oil, sorbitan stearate, tocopherol, water.

Storage And Handling

OTHER INFORMATION
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Package Label.Principal Display Panel

ERBAORGANICSSPF30BROAD SPECTRUM SUNSCREENCompletely natural water resistant (80 minutes)sunscreen for children and adults.

* Please review the disclaimer below.