FDA label b8a65eaa-34a6-0dea-e053-2a95a90a0d06

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
839851fb-a743-478c-90e3-125d59027847
SPL ID
b8a65eaa-34a6-0dea-e053-2a95a90a0d06
Version
3
Effective date
2021-01-11
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:00

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months ask a doctor. 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-sleeve shirts, pants, hats, and sunglasses. Inactive ingredients Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Glyceryl Stearate, Saccharide Isomerate, Fragrance/Parfum, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Panthenol, Tocopheryl Acetate. Camellia Sinensis Leaf Extract, Trisodium EDTA, Ethylhexylglycerin, Methylisothiazolinone.

Reported adverse events (FAERS/openFDA)#

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