FDA label b8a8f628-94c9-9509-e053-2a95a90a683b

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
d4f54fae-76a3-4203-b787-719f81dbcd39
SPL ID
b8a8f628-94c9-9509-e053-2a95a90a683b
Version
3
Effective date
2021-01-11
Source export date
2026-11-06
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:21:24

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 Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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, PEG-8 Beeswax/Cera Alba, Glyceryl Stearate, Dimethicone, Butyl Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Ceteth-20, Steareth-20, Sodium PCA, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Dimethicone Crosspolymer, Saccharide Isomerate, Hydrogenated Avocado Oil, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycyrrhiza Glabra (Licorice) Extract, Butylene Glycol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Avena Sativa (Oat) Kernel Extract Glycolipids, Soybean Phytosterols, Sodium Hyaluronate, Panthenol, Tocopheryl Acetate, Ethylhexylglycerin, Methylisothiazolinone, Trisodium EDTA, Cistus Incanus Extract, Maltodextrin

Reported adverse events (FAERS/openFDA)#

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