FDA.reportPublic FDA data

FDA label 8f3e090a-3d0e-479c-ac5b-8a3dd69ecc00

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
99a522f3-0931-4ced-84a6-6123cf34f79a
SPL ID
8f3e090a-3d0e-479c-ac5b-8a3dd69ecc00
Version
1
Effective date
2013-09-25
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:15

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings: For external use only. When using this product avoid contact with eyes • If contact occurs, rinse with water to remove. Stop use and ask Doctor if rash or irritation develops and lasts. Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately.

warnings and cautions

Active Ingredient Zinc Oxide (10.8%) Titanium Dioxide (4.9%)

warnings and cautions

Sun Protection Measure Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.