FDA label 3bb1c503-1397-4ef4-be81-212e29325309

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
8f9b8c20-96b7-45ef-9b8d-980996de9168
SPL ID
3bb1c503-1397-4ef4-be81-212e29325309
Version
5
Effective date
2017-05-15
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:18

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. - 2p.m. wear long-sleeve shirts, pants, hats and glasses Water/Aqua, Caprylic/Capric Triglyceride, Dimethicone, PEG-8 Beeswax/Cera Alba, Glyceryl Stearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Saccharide Isomerate, Cetyl Alcohol, Ceteth-20, Steareth-20, Glycerin, Hemidesmus Indicus Extract, Glycyrrhiza Glabra (Licorice) Extract, Withania Somnifera Extract, Butylene Glycol, Methylsilanol Mannuronate, Sodium PCA, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Glycerin, Hydrogenated Avocado Oil, Dimethicone, Dimethicone Crosspolymer, Cetyl Alcohol, Phenoxyethanol, Hexylene Glycol, Potassium Sorbate, Butyrospermum Parkii (Shea Butter) Fruit, propylene Glycol, Codium Tomentosum Extract, Acrylates Copolymer, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Fragrance/Parfum, panthenol, Tocopheryl Acetate, Trisodium EDTA, Glycine Soja (Soybean) Seed Extract, Ceramide3, Glyceryl Polymethacrylate, Palmitoyl Oligopeptide, Red 33/CI 17200, Blue 1/CI 42090, Pentylene Glycol, Propamidobenzoic Acid, Zingiber Officinale (Ginger) Extract, Bisabolol

Reported adverse events (FAERS/openFDA)#

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