FDA.reportPublic FDA data

BROAD SPECTRUM SPF50 SPF 50

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)

Brand name
BROAD SPECTRUM SPF50 SPF 50
Generic name
AVOBENZONE, HOMOSALATE OCTISALATE,
Manufacturer
NAKED SUNDAYS PTY LTD
Product type
HUMAN OTC DRUG
SPL set ID
0426b1e9-063b-c1e6-e063-6294a90a2554
SPL ID
481ba0d9-ff2b-95f2-e063-6394a90a5744
Version
8
Effective date
2026-01-11
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:38:48
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS Warnings: For external use only. 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 help prevent sunburn, not skin cancer or early skin aging. Do not use on damaged or broken skin. When using this product: Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: If rash occurs. Keep out of reach of children: If product is swallowed, get medical help or contact a Poison Control Center right away. Use a water-resistant sunscreen if swimming or sweating. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 3 years of age: 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses

warnings and cautions

Directions: Apply generously 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours. Children under 6 months of age: 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 10AM - 2PM Wear long-sleeved shirts, pants, hats, and sunglasses

Reported adverse events (FAERS/openFDA)#

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