FDA.reportPublic FDA data

COLLAGEN GLOW CREME

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2021-09-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:35:33

Label at a glance#

ProductCOLLAGEN GLOW CREME SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
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 generously15 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...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Octilsalate 5%
Octocrylene 10%

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.
  • Keep out of reach of children: If product is swallowed, get medical help.

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 generously15 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

Dimethicone 350, Ethylhexylglycerin, Glyceryl monostearate, Hydrolysed adansonia digitata leaf extract, Enzacamene, Hydrolysed rice protein, Hydrolysed soy protein, Phenoxyethanol, Potassium cetyl phosphate, Proline, Water (Aqua), Sodium benzoate, Sodium polyacrylate, Citrulius lanatus fruit extract (Watermelon).

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81104-101-112025-07-18C16284748780-1f386c649-adef-0266-e053-dadaa90a7c1aNAKED SUNDAYS COLLAGEN GLOW CREME SPF 50
81104-101-112023-01-30C16284748780-1f386c649-adef-0266-e053-dadaa90a7c1aNAKED SUNDAYS COLLAGEN GLOW CREME SPF 50

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81104-101COLLAGEN GLOW CREME SPF 50 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [NAKED SUNDAYS PTY LTD]3Legacy NDC20210917_4deabe0f-af83-41b1-9484-70d950428259.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81104-10181104-101-11
30807-1006

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE 3502Y53S6ATLUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ADANSONIA DIGITATA LEAFG75S8RQS56IACT
ENZACAMENE8I3XWY40L9IACT
ORYZA SATIVA WHOLE84IVV0906ZIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PROLINE9DLQ4CIU6VIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
WATERMELON231473QB6RIACT
AVOBENZONEG63QQF2NOXACTIB
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
3a314d1c-b6f5-2127-e063-6394a90a3aeb4deabe0f-af83-41b1-9484-70d9504282592025-07-18WarningsExact identifier
spl set id: 4deabe0f-af83-41b1-9484-70d950428259

Reported adverse events (FAERS/openFDA)#

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