FDA label 4c548ab4-9bee-4e93-8af2-9b35bab3ec87

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
976a579d-ec34-450e-b8f4-33fa68617b41
SPL ID
4c548ab4-9bee-4e93-8af2-9b35bab3ec87
Version
1
Effective date
2013-03-27
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 06:31:14

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. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Directions Apply liberally 15 minutes before sun exposure 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 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 Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor Water (Aqua/Eau), Titanium Dioxide, Caprylic/Capric Triglyceride, Propanediol, Cocoglycerides, Glyceryl Stearate, PEG-40 Stearate, Jojoba Esters, Glycerin, Isostearyl, Neopentanoate, Mica, Butyrospermum Parkii (Shea) Butter, Dimethicone, Phenethyl Benzoate, Beeswax, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, Cyclopentasiloxane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Phosphate, Isostearyl Hydroxystearate, Stearyl Alcohol, Phenoxyethanol, Cetearyl Alcohol, Tocopheryl Acetate, Acrylates/Dimethicone Copolymer, Imperata Cylindrica Root Extract, Caprylyl Glycol, Chlorphenesin, Silica.

Reported adverse events (FAERS/openFDA)#

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