FDA.reportPublic FDA data

CLEAR GLOW BROAD SPECTRUM SUNCREEN

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:58:21

Label at a glance#

ProductCLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Octocrylene 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed
with other sun protection measures (see directions),
decreases the risk of skin cancer and early skin
ageing caused by the sun.

WARNINGS

WARNINGS SECTION

Warnings: For external use only. Do not use on
damaged or broken skin. Avoid prolonged sun
exposure. If it gets in your eyes, wash well with
water. Keep out of reach of children. Stop use
and ask a doctor if rashes occur. If product is
swallowed, get medical help or contact a Poison
Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Medium Chain
Triglycerides, Ceresin, Dicaprylyl Carbonate,
Butyloctyl Salicylate, Polyethylene, Citrillus Lanatus

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

RECENT MAJOR CHANGES SECTION

Helps prevent sunburn. If used as directed
with other sun protection measures (see directions),
decreases the risk of skin cancer and early skin
ageing caused by the sun.

USER SAFETY WARNINGS SECTION

Directions: Apply generously 15 minutes before
sun exposure. Use a water-resistant sunscreen if
swimming or sweating. Reapply immediately after
towel drying. 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 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 Children under 6 months of age: Ask a
doctor.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-984-11CLEAR GLOW BROAD SPECTRUM SUNCREENSPF 5019 g in 1 CONTAINERCREAM194

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81104-984CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50 (AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENE) CREAM [NAKED SUNDAYS PTY LTD]4Current NDC, 1 package rows20250403_0116cffa-3415-746b-e063-6394a90ab3b3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81104-98481104-984-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
TOMATO JUICEU4475AYH9CIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD0116cffa-3415-746b-e063-6394a90ab3b32025-04-01WarningsExact identifier
ndc (package): 81104-984-11
ndc (product): 81104-984
ndc11 (package): 81104098411
spl id: 31bab90f-8379-6f7c-e063-6294a90a1562
spl set id: 0116cffa-3415-746b-e063-6394a90ab3b3

Reported adverse events (FAERS/openFDA)#

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