FDA label 1ee6cf19-1141-4033-a763-ecaa7cee7393

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
6aee8288-0def-40fc-81f0-604901ccc4a1
SPL ID
1ee6cf19-1141-4033-a763-ecaa7cee7393
Version
3
Effective date
2019-06-13
Source export date
2026-10-12
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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:27

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 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, Diisopropyl Sebacate, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI77492/CI 77499, Stearic Acid, PEG-8, Cyclomethicone, Squalane, Mica, Glyceryl Stearate, PEG-100 Stearate, Triethoxycaprylylsilane, Di-PPG-3 Myristyl Ether Adipate, Polysorbate 60, Ethylhexylglycerin, Polymethyl Methacrylate, Proanediol, Caprylyl Glycol, Hexylene Glycol, Methylisothiazolinone, Cetyl Alcohol, Magnesium Aluminum Silicate, Aminomethyl Propanol, Xanthan Gum, Tocopheryl Acetate, Butylene Glycol, Magnesium, Copper, Zinc Glycopeptides, Polydodecanamideaminium Triazadiphenylethenesulfonate, Polyvinylalcohol Crosspolymer, Carica papaya Extract, Glycyrhiza Glabra (Licorice)

Reported adverse events (FAERS/openFDA)#

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