FDA.reportPublic FDA data

HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:58:22

Label at a glance#

ProductHYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure8 sections

Indications and uses

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octilsalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

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.

WARNINGS

WARNINGS SECTION

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

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:
Water, Butyloctyl Salicylate, Ethylhexyl
Methoxycrylene, Dimethicone, Potassium
Cetyl Phosphate, Glyceryl Stearate, Sodium
Polyacrylate, Niacinamide, Tocopheryl
Acetate, Hydroxyacetophenone, Sodium
Benzoate, Glyceryl Caprylate, Sodium
Hyaluronate, Disodium EDTA, Citric Acid,
Sodium Hydroxide

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information:
Protect the product in this container
from excessive heat and direct 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.

INDICATIONS & USAGE SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-802-01HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50SPF 5050 mL in 1 CONTAINERCREAM506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81104-802HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 (AVOBENZONE, HOMOSALATE OCTISALATE,) CREAM [NAKED SUNDAYS PTY LTD]6Current NDC, 1 package rows20250403_04293280-e74a-f293-e063-6394a90a06f6.zip

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
81104-80281104-802-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
NIACINAMIDE25X51I8RD4IACT
WATER059QF0KO0RIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD04293280-e74a-f293-e063-6394a90a06f62025-04-01WarningsExact identifier
ndc (package): 81104-802-01
ndc (product): 81104-802
ndc11 (package): 81104080201
spl id: 31bad2aa-3719-1b84-e063-6394a90ae385
spl set id: 04293280-e74a-f293-e063-6394a90a06f6

Reported adverse events (FAERS/openFDA)#

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