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
Ingredient	Strength
AVOBENZONE	3 g/100mL
HOMOSALATE	10 g/100mL
OCTISALATE	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
04293280-e74a-f293-e063-6394a90a06f6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81104-802-01	HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50SPF 50	50 mL in 1 CONTAINER	CREAM	50		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81104-802	HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 (AVOBENZONE, HOMOSALATE OCTISALATE,) CREAM [NAKED SUNDAYS PTY LTD]	6	Current NDC, 1 package rows	20250403_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 246 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Badger SPF 30 Daily Sunscreen	ZINC OXIDE	W.S. Badger Company, Inc.	11e65bae-2361-5440-e063-6294a90a075e	2024-12-31	Warnings	Exact identifier application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	REVLON	d09ab4ca-6d5c-47bd-e053-2a95a90a409d	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Fair	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a947e1d-286f-a939-e063-6394a90a0719	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Tan	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94a668-24cb-e0f2-e063-6294a90a79d3	2024-12-31	Warnings	Exact identifier application number: M020
Almay Healthy Biome Makeup Medium	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a47-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a962944-9155-9b70-e063-6294a90ac535	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Medium	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a96811c-3ea6-15bc-e063-6394a90ac3bd	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Liquid Makeup for Normal to Dry Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	414538d6-9108-54bf-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Preo and Protect Primer	TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMER	Revlon Consumer Products Corp	8eebf23e-7fce-dfc0-e053-2995a90ae322	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Kiss Balm SPF 20	AVOBENZONE, BENZOPHENONE-3, OCTINOXATE	Revlon Consumer Products Corp	410d1cb2-6c90-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon PhotoReady BB Cream Skin Perfector	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410ca372-4698-029d-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Colorstay Liquid Makeup for Oily to Combination Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410d1cb2-6c92-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
REVLON PHOTOREADY INSTA-FIX MAKEUP	TITANIUM DIOXIDE, ZINC OXIDE	Revlon Consumer Products Corp	442f2a06-47c0-2522-e054-00144ff88e88	2024-12-31	Warnings	Exact identifier application number: M020
Revlon Youth FX	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	442dec1e-032c-28de-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Medium	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a971e38-af63-e069-e063-6294a90a8f77	2024-12-31	Warnings	Exact identifier application number: M020
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	d9209277-469d-48f4-bf64-f39a70c19596	2024-12-31	Warnings	Exact identifier application number: M020
Almay Smart Shade Skintone Matching Makeup Light	TITANIUM DIOXIDE ZINC OXIDE	Almay, Inc.	2a987b85-efdb-eb95-e063-6394a90aef81	2024-12-31	Warnings	Exact identifier application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Light	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a984dd9-7293-77f0-e063-6294a90a8f1e	2024-12-31	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	097fc15e-ea17-47b2-9581-19c5e11592f6	2024-12-30	Warnings	Exact identifier application number: M020
HERBAL UV DEFENSE SPF40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	2a76fd94-2f1f-e6d8-e063-6294a90a287c	2024-12-30	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81104-802-01	81104080201	50 mL in 1 CONTAINER (81104-802-01)	50 ml	2023-08-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50	NAKED SUNDAYS PTY LTD	2025-04-01	HUMAN OTC DRUG LABEL	6