FDA label b8b7df02-595b-0766-e053-2a95a90ae1ec

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
cb8ab0a9-7742-4a54-bc3d-4a5a35f231ab
SPL ID
b8b7df02-595b-0766-e053-2a95a90ae1ec
Version
3
Effective date
2021-01-12
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:00:59

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 Inactive Ingredients Water/Aqua, Aluminum, Starch Octenylsuccinate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Biosaccharide Gum-1, Azadirachta Indica Extract, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, Butylene Glycol, Decamethylcyclopentasiloxane, Fragrance/Parfum, DMDM Hydantoin, Panthenol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Trisodium EDTA, Tocopherol, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Avena Sativa (Oat) Kernel Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Ethoxylated Castor Oil, Cistus Incanus Extract, Maltodextrin, Lysine Thiazolidine Carboxylate

Reported adverse events (FAERS/openFDA)#

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