FDA label dd2e2774-4545-43e7-a423-4c53b97fdfbd

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
bfcf87c0-27c4-4fba-9f4e-77e7132e073a
SPL ID
dd2e2774-4545-43e7-a423-4c53b97fdfbd
Version
3
Effective date
2012-11-05
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:36

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

External use only. Do not use in on damaged or broken skin. Contains Oxybenzone. When using this product, keep out of eyes. Skin cancer/ Skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn and not skin cancer and early skin aging. Limit time in the sun 10 am to 2 p (North Hemisphere). Wear long-sleeve shirts, pants, hats and sunglasses. Children should avoid prolonged exposure to sunlight. Sunscreens do not prevent heat stroke. Product only available through a professional. How to use No water resistant product: Apply Liberally 15 minutes before sun exposure. Reapply at least every two hours. Apply generously before exposure to sun as much as needed. Apply again every 2 hours or immediately after having a bath, energetic activity, excessive perspiration or when using a towel to maintain product effectiveness. Children under 6 months: ask a doctor. Protect this product from excessive heat and sunlight. INCI Inactive Ingredients Deionized Water (aqua) * Propylene Glycol * Glycerin * Glyceryl Stearate * Cetyl Alcohol * Stearic Acid * Dimethicone * Aloe Barbadensis (Leaf Extract) * Hamamelis Liquid Extract (Hamamelis Virginiana Extract) * Polysorbate 20 * DMDM Hydantoin * Methylparaben * propylparaben * Iron Oxides (CI:77.491, CI:77.492, CI 77.499) * Acrylates/C10-30 Alkyl Acrylate Crosspolymer * Shea butter (Butyrospermum Parkii Butter) * Xanthan Gum * Tocopheryl Acetate (vitamin E acetate) * Triethanolamine * Fragrance (Parfum) * BHT.

Reported adverse events (FAERS/openFDA)#

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