FDA label 219c4389-6196-4736-9f8a-5b9488a2e85d

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
13c8403a-89be-4ed2-a849-86b26d13bfef
SPL ID
219c4389-6196-4736-9f8a-5b9488a2e85d
Version
6
Effective date
2017-05-10
Source export date
2026-10-12
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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:29

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 evey 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. -2 p.m. wear long-sleeve shirts, pants, hats and sunglasses water/aqua, aluminum startch octenylsuccinate, sodium polyacrylate, hydrogentated polydecene, trideceth-6, phenoxyethanol, hexylene glycol, caprylyl glycol, potassium sorbate, saccharide isomerate, decamethylcylcopentasiloxane, azadirachta indica extract, tagetus erecta (AFrican Marigold) Extract, Ipomoea Digitata (Fingerleaf Morning Glory) Butylene Glycol, Panthenol, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Lysine Carboxymethyl Cysteinate, Lysine Thiazolidine Carboxylate, DMDM Hydantoin, Tocopheryl Acetate, Trisodium EDTA, Malic Acid, Hydrolyzed Prunus Amygdalus Dulcis (Sweet Almond) Protein, Butyl Avocadate, Fragrance/Parfum, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polysorbate 20, Ethoxylated Castor Oil, Blue 1/CI 42090, Yellow 5/CI 19140, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Zingiber Officinale (Ginger) Extract, Bisabolol

Reported adverse events (FAERS/openFDA)#

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