Cancer Council Protect and Hydrate Radiance SPF50 Plus

Product NDC: 84258-002
Requested package NDC: 84258-002-01
11-digit product format: 842580002
Labeler code: 84258
Product ID: 84258-002_1622c351-6e6a-eeaf-e063-6294a90acd25
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: Vitality US Co.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-19
Substance: HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength: 100; 80; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Cancer Council Protect and Hydrate Radiance SPF50 Plus
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	100 mg/mL
OCTOCRYLENE	80 mg/mL
OCTISALATE	50 mg/mL
AVOBENZONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	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
1622c351-6e69-eeaf-e063-6294a90acd25	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84258-002-01	Cancer Council Protect and Hydrate Radiance SPF50 Plus	1 in 1 CARTON	LOTION	1		1
84258-002-01	Cancer Council Protect and Hydrate Radiance SPF50 Plus	148 mL in 1 TUBE	LOTION	148		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84258-002	CANCER COUNCIL PROTECT AND HYDRATE RADIANCE SPF50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [VITALITY US CO.]	1	Current NDC, 2 package rows	20240920_1622c351-6e69-eeaf-e063-6294a90acd25.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 132 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Mattify Total Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN SLATE SKIN & BODY, INC.	37617bd5-c275-aeee-e063-6394a90a214d	2025-12-11	Exact identifier application number: M020
Not YO 80s Zinc Sunscreen	ZINC OXIDE	CLEAN SLATE SKIN & BODY, INC.	37644dfd-e96d-a783-e063-6294a90a9796	2025-12-11	Exact identifier application number: M020
Not YO 80s Zinc Sunscreen	ZINC OXIDE	CLEAN SLATE SKIN & BODY, INC.	3762f132-4ab0-74ad-e063-6394a90a436c	2025-12-11	Exact identifier application number: M020
GLOW UP Ageless Daily Protection Sunscreen	ZINC OXIDE	CLEAN SLATE SKIN & BODY, INC.	37637e45-c6ed-12ca-e063-6294a90aeb02	2025-12-11	Exact identifier application number: M020
Face and Body Sunscreen	ZINC OXIDE	SCIENCE CEUTICALS, LLC	369b42f3-5203-87c4-e063-6394a90a6284	2025-12-11	Exact identifier application number: M020
Nourish Non-Tinted Mineral Sunscreen	ZINC OXIDE	Fern Burg	34a32097-de93-9b1d-e063-6394a90a41df	2025-12-11	Exact identifier application number: M020
Mattify Total Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN SLATE SKIN & BODY, INC.	37641f8b-0133-8bfc-e063-6294a90aac5c	2025-12-11	Exact identifier application number: M020
GLOW UP Ageless Daily Protection Sunscreen	ZINC OXIDE	CLEAN SLATE SKIN & BODY, INC.	3764856a-98c5-334e-e063-6394a90a629d	2025-12-11	Exact identifier application number: M020
Essential Mineral Sun Protection	TITANIUM DIOXIDE, ZINC OXIDE	Fern Burg	34a360b2-6798-c7e8-e063-6294a90a5cbb	2025-12-11	Exact identifier application number: M020
Nourish Non-Tinted Mineral Sunscreen	ZINC OXIDE	Fern Burg	34a3e268-e376-11a0-e063-6294a90a46af	2025-12-11	Exact identifier application number: M020
Tinted Mineral Matte CE Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Maui Medical Group, Inc	34b72d14-b69b-e9dd-e063-6394a90a748e	2025-12-11	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE CEUTICALS, LLC	369b20e2-2cad-e047-e063-6294a90a1bba	2025-12-11	Exact identifier application number: M020
Tinted Mineral Matte CE Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Maui Medical Group, Inc	34b60880-5fe1-b78f-e063-6294a90a748d	2025-12-11	Exact identifier application number: M020
Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Maui Medical Group, Inc	34b51190-6a6d-c5e0-e063-6394a90ae875	2025-12-11	Exact identifier application number: M020
Tinted Ultra Zinc Face and Body	ZINC OXIDE	LIV BODY AND BEAUTY LLC	374fae34-41b9-4cab-e063-6394a90a9b1d	2025-12-11	Exact identifier application number: M020
Z Bloc	ZINC OXIDE	The Maui Medical Group, Inc	34b64eb5-a91f-de43-e063-6294a90a8043	2025-12-11	Exact identifier application number: M020
Sheer Tinted Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	The Maui Medical Group, Inc	34b6e8d0-6235-dac2-e063-6394a90afefd	2025-12-11	Exact identifier application number: M020
Tinted Sunscreen Face Primer	TITANIUM DIOXIDE, ZINC OXIDE	LIV BODY AND BEAUTY	374f6b79-2ac4-61cf-e063-6394a90a699b	2025-12-11	Exact identifier application number: M020
Non Tinted Ultra Zinc Face and Body	ZINC OXIDE	LIV BODY AND BEAUTY LLC	375008f2-8dd4-aa31-e063-6394a90a5be8	2025-12-11	Exact identifier application number: M020
Replenishing Daily Protection	ZINC OXIDE	The Maui Medical Group, Inc	34b96d82-7fcf-e452-e063-6394a90a781b	2025-12-11	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84258-002-01	84258000201	1 TUBE in 1 CARTON (84258-002-01) / 148 mL in 1 TUBE	1 tube	2024-09-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cancer Council Protect and Hydrate Radiance SPF50 Plus	Vitality US Co.	2024-04-15	HUMAN OTC DRUG LABEL	1