FDA label d7647547-09ab-438e-90cc-b07700ec9796

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
0792a64c-46f0-4af6-b5c4-11619ea2bdb2
SPL ID
d7647547-09ab-438e-90cc-b07700ec9796
Version
14
Effective date
2016-06-27
Source export date
2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:24

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. Stop use and ask a doctor if rash occurs keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away Directions Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours. Sun Protection Measures Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor. Inactive Ingredients ALUMINA, BUTYLENE GLYCOL, CALCIUM CARBONATE, CAPRYLYL GLYCOL, CETYL PEG/PPG 10/1 DIMETHICONE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, GOSSYPIUM HERBACEUM(COTTON), HEXYL LAURATE, HEXYLENE GLYCOL, HYDROGENATED POLYISOBUTENE, LYCIUM BARBARUM FRUIT EXTRACT, MAGNESIUM SULFATE, MICA, MICROCRYSTALLINE WAX, PEG-10 DIMETHICONE, PENTAERYTHRITYL, TETRASISOSTERATE, PHENOXYETHANOL, POLYETHYLACRYLATE, POLYGLYCERYL-3 BEESWAX, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, QUATERNIUM-90 BENTONITE, SILICA, SILICA DIMETHYL SILYLATE, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYALURONATE, STEARIC ACID, TREBEHENIN, TRIETHOXYLCAPRYLYLSILANE, WATER. MAY CONTAIN (+/-): IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI77499), TITANIUM DIOXIDE (CI77891). Other Information Protect this product from excessive heat and direct sun. Questions or comments? Call toll free 855-201-4529

Reported adverse events (FAERS/openFDA)#

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