FDA.reportPublic FDA data

COLLAGEN GLOW MINERAL SUNSCREEN

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:12:50

Label at a glance#

ProductCOLLAGEN GLOW MINERAL SUNSCREEN SPF 50
Active ingredientZINC OXIDE
Label structure7 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.

Dosage and administration

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 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 high...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.75%

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

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: rash occurs.
  • CONTAINS SODIUM BENZOATE.

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

  • 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 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

CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ,COCO-CAPRYLATE (UNII: 4828G836N6) ,EDETATE DISODIUM (UNII: 7FLD91C86K),GLUCONOLACTONE (UNII: WQ29KQ9POT),ADANSONIA DIGITATA SEED (UNII: 2936P60TPX), ORYZA SATIVA WHOLE (UNII: 84IVV0906Z),HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6),ISOSTEARIC ACID (UNII: X33R8U0062),TRICAPRIN (UNII: O1PB8EU98M),OCTYLDODECANOL (UNII: 461N1O614Y),PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO),POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
PROLINE (UNII: 9DLQ4CIU6V),WATER (UNII: 059QF0KO0R),SODIUM BENZOATE (UNII: OJ245FE5EU),SODIUM CHLORIDE (UNII: 451W47IQ8X),ETHYLHEXYLGLYCERIN (UNII: 147D247K3P),PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)

OTHER INFORMATION

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2211

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-100-01COLLAGEN GLOW MINERAL SUNSCREENSPF 5050 mL in 1 TUBELOTION503
81104-100-02COLLAGEN GLOW MINERAL SUNSCREENSPF 5020 mL in 1 TUBELOTION203

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81104-10081104-100-01, 81104-100-02

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
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO-CAPRYLATE4828G836N6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLUCONOLACTONEWQ29KQ9POTIACT
ADANSONIA DIGITATA SEED2936P60TPXIACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
ISOSTEARIC ACIDX33R8U0062IACT
TRICAPRINO1PB8EU98MIACT
OCTYLDODECANOL461N1O614YIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
PROLINE9DLQ4CIU6VIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC OXIDESOI2LOH54ZACTIM
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT

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
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD388fb3db-29d2-bb29-e063-6394a90a4efb2025-09-08WarningsExact identifier
ndc (package): 81104-100-02
ndc (package): 81104-100-01
ndc (product): 81104-100
ndc11 (package): 81104010001
ndc11 (package): 81104010002
spl id: 3e4cf991-4ebd-109d-e063-6394a90ab9f6
spl set id: 388fb3db-29d2-bb29-e063-6394a90a4efb

Reported adverse events (FAERS/openFDA)#

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