FDA label c37afa74-f826-47ca-80ea-eeff9e0bd44c

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
42575df5-27eb-46e7-a00b-7df887d1272f
SPL ID
c37afa74-f826-47ca-80ea-eeff9e0bd44c
Version
4
Effective date
2017-05-11
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:05:05

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 and cautions

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 Octenlsuccinate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Saccharide Isomerate, Decamethylcyclopentasiloxane, Azadirachta Indica Extract, Tagetus Erecta (African Marigold) Extract, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Butylene Glycol, Panthenol, Chondrus Crispus (carageenan) Extract, Biosaccharide Gum-4, Lysine Thiazolidine Carboxylate, DMDM Hydantoin, Tocopheryl Acetate, Trisodium EDTA, Malic Acid, Hydrolyzed Prunus Amygdalus Dulcis (Sweet Almond) Protein, Butyl Avocadate, Fragrance/Parfum, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Ethoxylated Castor Oil, Blue 1/CI42090, 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.