FDA label 4d5ec995-dc2e-44ab-a52b-a70429d75632

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
704c326a-e50f-4d10-ae1f-f403e76c4c9c
SPL ID
4d5ec995-dc2e-44ab-a52b-a70429d75632
Version
3
Effective date
2016-04-20
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 02:21:22

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 · 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 · Reapply at least every 2 hours · Use a water resistant sunscreen if swimming or sweating · Children under 6 months: Ask a doctor Ethylhexyl Palmitate, Ozokerite, C12-15 Alkyl Benzoate, Paraffin, Beeswax, Isopropyl Palmitate, Euphorbia Cerifiera (Candellila) wax, Phenoxyethanol, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Polysilicone-15, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Punica Granatum Seed Oil, Persea Gratissima (Avocado) Oil, Oenothera Biennes, (Evening Primrose) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Tocopherol, BHT, Santalum Album (Sandalwood) Wood Extract, Prunus Armeniaca (Apricot) Fruit Extract, Cucumis Melo Cantalupensis Fruit Extract, Vanilla Planifolia Fruit Extract, Rubus Ideaus (Raspberry) Fruit Extract, Rose Extract, Prunus Amygdalus Dulcis (sweet Almond) Fruit Extract, Passiflora Incarnata Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Coffea Arabica (Coffee) Seed Extract, Cocos Nucifera (coconut) Fruit Extract, Citrus Grandis (Grapefruit) peel Extract, Cananga Odorata Flower Extract, Butter Extract, Aniba Rosaeodora (Rosewood) Wood extract, Ananas Sativus (Pineapple) Fruit Extract, Aloe Barbadensis Leaf Extract

Reported adverse events (FAERS/openFDA)#

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