FDA.reportPublic FDA data

Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8g

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:37

Label at a glance#

ProductNaked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8g
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 23.75 %

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Iron Oxides (CI77491, CI77492, CI 77499), Isostearic Acid, Palmitoyl Hexapeptide-12, Pentaerythrityl Tetraisostearate, Polyglyceryl-3 Polyricinoleate, Propylene Carbonate, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Tapioca Starch, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate,OZOKERITE

INDICATIONS & USAGE SECTION

Use: 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

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. Stop use and
ask a doctor: If skin rash occurs.
Keep out of reach of children. If
product is swallowed, get medical
help or contact a Poison Control
Center right away.

USER SAFETY WARNINGS SECTION

Directions: Apply liberally and
evenly 15 minutes before sun
exposure. Reapply at least every 2
hours or immediately after swimming,
sweating or towel drying. Use a
water-resistance sunscreen if
swimming or sweating. 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
10.00AM - 2.00PM Wear
long-sleeved shirts, pants, hats, and
sunglasses.

OTHER SAFETY INFORMATION

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

OTC - QUESTIONS SECTION

Questions:
info@nakedsundays.com

OTC - PURPOSE SECTION

SPF Sunscreen

DOSAGE & ADMINISTRATION SECTION

Directions: Apply liberally and
evenly 15 minutes before sun
exposure. Reapply at least every 2
hours or immediately after swimming,
sweating or towel drying. Use a
water-resistance sunscreen if
swimming or sweating.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-105-01Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8g8 g in 1 PACKAGESTICK84

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81104-10581104-105-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
CI 774911K09F3G675IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
COPERNICIA CERIFERA (CARNAUBA) WAXR12CBM0EIZIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
CI 77499XM0M87F357IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TAPIOCA STARCH24SC3U704IIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ISOSTEARIC ACIDX33R8U0062IACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8gZINC OXIDENAKED SUNDAYS PTY LTD2f441311-b41c-d4e8-e063-6394a90a697a2025-11-17WarningsExact identifier
ndc (package): 81104-105-01
ndc (product): 81104-105
ndc11 (package): 81104010501
spl id: 43cdead4-bd7b-45f2-e063-6294a90abd14
spl set id: 2f441311-b41c-d4e8-e063-6394a90a697a

Reported adverse events (FAERS/openFDA)#

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