FDA label c7b20126-184e-4adc-8ed8-eca9532f1497

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
0473f576-71f3-4732-a38a-a59cdc78fe27
SPL ID
c7b20126-184e-4adc-8ed8-eca9532f1497
Version
3
Effective date
2017-05-10
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:35:45

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 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 Water/aqua, Hydroxyethyl Acrylate/sodium Acryloyldimethyltaurate Copolymer, Squalane, Polysorbate 60, Tridecyl Neopentanoate, Aluminum starch Octenylsuccinate, Saccharide Isomerate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Butylene Glycol, Avena Sativa (Oat) Kernal Extract, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycyrrhiza, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Panthenol, Tocopheryl Acetate, Dimethicone, Pueraria Lobata Root Extract, Trisodium EDTA, Pentylene Glycol, Hydroxyphenyl propamidobenzoic Acid

Reported adverse events (FAERS/openFDA)#

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