FDA label b8a96553-d531-bdd0-e053-2995a90a1480

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
c257dfc3-f15e-48ab-a1e5-04696f9c47d8
SPL ID
b8a96553-d531-bdd0-e053-2995a90a1480
Version
4
Effective date
2021-01-11
Source export date
2026-08-17
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/2026-08-17/1b5caad1d26c65d5be0ee71b8eb1373f0c7d99e6d83d2bfe99382f282ec02e02/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:45:38

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 Adipic Acid/Diglycol Crosspolymer, Alumina, Avena Sativa (Oat) Kernel Extract, Beeswax/Cera Alba, Butylene Glycol, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Dimethicone Copolyol, DMDM Hydantoin, Ethylhexyl Ethylhexanoate, Fragrance/Parfum, Glyceryl Stearate SE, Iodopropyl Butylcarbamate, Iron Oxides/CI 77491/CI 77492/CI 77499, Panthenol, PEG-4 Laurate, Peg-12 Dimethicone, PVP/Eicosene Copolymer, Sodium Dihydroxycetyl Phosphate Tocopheryl Acetate, Trisodium EDTA, Water/Aqua, Xanthan Gum