Standard Procedure SPF 50 Sunscreen

Product NDC: 84425-101
11-digit product format: 844250101
Labeler code: 84425
Product ID: 84425-101_4862fbef-e8ad-cc4b-e063-6394a90a35f2
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Standard Procedure Inc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-15
Substance: OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength: 80; 30; 100; 50 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: Standard Procedure SPF 50 Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
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
1d3f87de-90c0-75c0-e063-6394a90a2ef4	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	SPL version
84425-101-01	Standard Procedure SPF 50 Sunscreen	60 mL in 1 BOTTLE, PLASTIC	LOTION	60	2
84425-101-03	Standard Procedure SPF 50 Sunscreen	250 mL in 1 BOTTLE, PLASTIC	LOTION	250	2
84425-101-04	Standard Procedure SPF 50 Sunscreen	500 mL in 1 BOTTLE, PLASTIC	LOTION	500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84425-101	STANDARD PROCEDURE SPF 50 SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [STANDARD PROCEDURE INC]	1	Current NDC, 3 package rows	20240821_1d3f87de-90c0-75c0-e063-6394a90a2ef4.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 289 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	105651f2-3c99-4ff3-b67b-350a40dc8888	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7b1b551b-e78d-47ff-bb91-0d5f676c73fc	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2411e8e6-a958-4fd9-b5e9-b9a32020ce54	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	062f61d2-a9a7-46e1-92e4-a6bdf257c188	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9c3d513f-8331-4155-a77b-c358093a607c	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7f8d1d0-1734-46a5-82fe-b0ac14017522	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3849d5c-4f91-4147-aeb2-7461a3a94309	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e8f29488-10f8-4df6-b1f5-d9a670f60fca	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	86e0d1e4-3207-49e6-b5fa-e63f4ca300db	2024-08-06	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd67b009-accc-6c7b-e053-6294a90ad80e	2024-08-06	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Continuous SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	fd67fa5d-f997-c607-e053-6294a90aee2b	2024-08-06	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd66ee9b-5a24-776a-e053-6294a90a6559	2024-08-06	Warnings	Exact identifier application number: M020
SANTO REMEDIOS RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF 42 IVORY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	0708ec87-16c4-412b-971b-d4572931c780	2024-08-05	Warnings	Exact identifier application number: M020
EltaMD UV Physical SPF41	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	8fdc04eb-4079-40e3-a1b3-be4a542cf99a	2024-08-05	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6377c0f7-e2cb-44f0-9786-42c5a9d02f88	2024-08-04	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	e98696d2-7f7f-4a4c-b8ae-849f2d211a04	2024-08-04	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	f31842f7-3474-4462-87e2-c4ebde97a583	2024-08-04	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ccfafefc-fff4-41ff-baf4-3f430c690be7	2024-08-04	Warnings	Exact identifier application number: M020
Alba Botanica Sheer Mineral SPF50	ZINC OXIDE	The Hain Celestial Group, Inc.	f4a02196-288e-1958-e053-2a95a90a5305	2024-07-31	Warnings	Exact identifier application number: M020
Very Emollient Body Daily Shade SPF15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Hain Celestial Group	8eeb25a8-337d-c71b-e053-2995a90a091a	2024-07-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
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
84425-101-01	84425010101	60 mL in 1 BOTTLE, PLASTIC (84425-101-01)	60 ml	2024-07-15	No	No	Current
84425-101-03	84425010103	250 mL in 1 BOTTLE, PLASTIC (84425-101-03)	250 ml	2024-07-15	No	No	Current
84425-101-04	84425010104	500 mL in 1 BOTTLE, PLASTIC (84425-101-04)	500 ml	2024-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Standard Procedure SPF 50 Sunscreen - Standard Procedure Inc	Standard Procedure Inc	2026-01-14	HUMAN OTC DRUG LABEL	2