FDA label b8a96553-d527-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
84fd621d-637b-42a4-afe9-31bfccee5f96
SPL ID
b8a96553-d527-bdd0-e053-2995a90a1480
Version
10
Effective date
2021-01-11
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:26

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 rapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 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 Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Bisabolol, Butyrospermum Parkii(Shea Butter) Fruit, Caprylyl Glycol, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Fragrance/parfum, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Moringa Oliefera Extract, Octyldodecyl Neopentanoate, Panthenol, Phenoxyethanol. Polyester-8, Polysorbate 20, Potassium Sorbate, Sorbitan Oleate, Thermus Thermophillus Ferment, Tocopheryl Acetate, Triethanolamine, Trisodium EDTA, Vetivera Zinzanoids (Khus Root) Extract, Water/Aqua, Withania Somniferia (Winter Cherry) Extract, Zingiber Officinale (Ginger) Extract.

Reported adverse events (FAERS/openFDA)#

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