HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50

Product NDC
81104-802
11-digit product format
811040802
Labeler code
81104
Product ID
81104-802_31bad2aa-3719-1b84-e063-6394a90ae385
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, Homosalate OCTISALATE,
Dosage form
CREAM
Route
TOPICAL
Labeler
NAKED SUNDAYS PTY LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-30
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
3; 10; 5 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04293280-e74a-f293-e063-6394a90a06f6Available on FDA.report

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

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 261 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29227121-e579-8eea-e063-6394a90a302f2024-12-13WarningsExact identifier
application number: M020
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONEBobbi Brown Professional Cosmetics Inc.03372376-ef03-943d-e063-6394a90a52ee2024-12-13WarningsExact identifier
application number: M020
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.fbd04b66-738b-2762-e053-6394a90a8b722024-12-13WarningsExact identifier
application number: M020
Mentholatum Natural Ice CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company33f43f14-8e0b-41b1-8ad0-5723d2a7bf192024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 8 SunscreenZINC OXIDEAbsolutely Naturala26217cf-22ab-4c39-980a-b73467e16b912024-12-13WarningsExact identifier
application number: M020
Calming Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienced681cdb5-307e-4a2a-8e1d-2b29131d48d02024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Natural8084a3ee-fe31-4cb4-8d3c-e4035d29e5612024-12-13WarningsExact identifier
application number: M020
Mineral Corrector Palette SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescienceab70122f-bd68-4781-841f-dc83284e14032024-12-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC0a0654cc-ad47-2167-e063-6294a90a52f42024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEBabo Botanicals, Inc.f8adda52-e909-1905-e053-6294a90a3c782024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.f8b1ea3a-d62e-e00d-e053-6394a90a56892024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50ZINC OXIDEBabo Botanicals, Inc.f8b272f6-8726-de1d-e053-6294a90a7b1e2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Sport Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.e3ca7840-4882-d605-e053-2a95a90af6ab2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural GlowMINERAL SUNSCREENBabo Botanicals, Inc.ab39d9f0-d869-6f33-e053-2995a90a08d42024-12-12WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Extra Light TintZINC OXIDEMV Advanced7834c649-5f6d-b005-e053-2a91aa0a10842024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Light TintZINC OXIDEMV Advanced783649af-d746-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Medium TintZINC OXIDEMV Advanced783649af-d768-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Babo SPF 30 Clear Zinc Fragrance Free SportMINERAL SUNSCREENBabo Botanicals, Inc.b1a9f76d-0cef-29da-e053-2995a90af34c2024-12-12WarningsExact identifier
application number: M020
Babo Baby Face Mineral SunscreenMINERAL SUNSCREENBabo Botanicals, Inc.b131664d-1ad2-0a2f-e053-2995a90acbda2024-12-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81104-802-018110408020150 mL in 1 CONTAINER (81104-802-01) 50 ml2023-08-30NoNoCurrent