FDA.reportPublic FDA data

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 100 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect Glow BB Cream Sunscreen SPF 30 - Light WarmOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47325530-b097-db9a-e063-6294a90a335d2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47328eb4-8ad7-28b5-e063-6294a90a20b12025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732bbec-d9f9-1639-e063-6394a90aff822025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732ecd0-5261-7f11-e063-6394a90a26f32025-12-30WarningsExact identifier
application number: M020
ScalpProtectionSpraySCALP PROTECTION SPRAYNaturich Labsc227ff3a-bbbb-5cc5-e053-2a95a90a8e322025-12-30WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0439b4b6-2792-3af1-e063-6294a90adcfe2025-12-30WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0918fdd3-cffb-78e9-e063-6394a90ad5c72025-12-30WarningsExact identifier
application number: M020
SLMDAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONESkin PS Brands1aa36c01-21b5-f06e-e063-6294a90a608f2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - FairHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC473738b4-7c36-8edf-e063-6394a90ad24b2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47387d5f-e77b-5633-e063-6294a90a55842025-12-30WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05b7aa44-cf8f-d77a-e063-6394a90a850b2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738be66-0fe8-148e-e063-6394a90a1b022025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738eed1-9f72-5fd8-e063-6394a90a26bd2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4739179e-88b3-8820-e063-6394a90aa2112025-12-30WarningsExact identifier
application number: M020
WHITE TEA TINTED MOISTURIZERWHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREENGLOW CONCEPT INCeb2df93f-6cdc-7ae8-e053-2a95a90a00912025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30ZINC OXIDEKokua Sun Caref9a12dac-2fd0-798f-e053-6394a90aa7842025-12-29WarningsExact identifier
application number: M020
Calming Days Vegan Sunscreen,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEMERCYCO Co., Ltd.38898014-eefe-73ec-e063-6394a90a37382025-12-29WarningsExact identifier
application number: M020
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20SUNSCREEN OILSoleil Collective LLC471b3028-2c13-ab70-e063-6394a90aa6602025-12-29WarningsExact 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