FDA label b3ef4fa9-cf50-ba77-e053-2a95a90ac92c

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
25f0dd2a-0465-49fb-ba11-f3596df2d968
SPL ID
b3ef4fa9-cf50-ba77-e053-2a95a90ac92c
Version
9
Effective date
2020-11-12
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:58:23

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. If swallowed, get medical help or contact a poison control center right away. If condition worsens or does not improve within 7 days, consult a doctor. Directions · Apply liberally 15 minutes before sun exposure -Reapply liberally as often as necessary · Use a water resistant sunscreen if swimming or sweating · Children under 6 months: Ask a doctor Reapply at least every 2 hours · 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. Inactive Ingredients- Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) wax, Copernicia cerifera (carnauba) Wax, Polysiilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (coconut) Fruit Extract

Reported adverse events (FAERS/openFDA)#

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