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 312 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Tekweld Solutions, Inc.	ea9f4d57-b00c-48ce-b833-9690be98bffd	2023-12-26	Warnings	Exact identifier application number: M020
Best Skin Days BS SPF 30	ZINC OXIDE	Allure Labs	0d7072f8-e808-5270-e063-6294a90a1ffa	2023-12-26	Warnings	Exact identifier application number: M020
Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	f0d6518b-d795-4740-a301-1804a932ec45	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow	OCTINOXATE	L'Oreal USA Products Inc	4f4a8c37-af08-4bf7-89bc-1e487417c146	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow	OCTINOXATE	SICOS ET CIE	7051f505-f874-4214-ad4f-55a956cc35a7	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	08645f1d-7ba7-4410-8600-3d3f79d71385	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	fc847725-b7a9-41f1-a605-d1d892fed06f	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	df67b49c-f8b6-4c0a-9e8d-c94dee3635ff	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	a9b7e52c-8799-49ba-8b05-7559fe6668fe	2023-12-23	Warnings	Exact identifier application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fair	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	32569352-c51e-4f05-a8b0-749ef916a5af	2023-12-22	Warnings	Exact identifier application number: M020
Circadia Circa-Shield Mineral Sunscreen SPF 30	ZINC OXIDE	Circadia by Dr Pugliese, Inc.	2959aa56-be7f-4721-9701-e6d6e12cc850	2023-12-22	Warnings	Exact identifier application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc	0adb52f5-4e1f-4570-9b6f-584e4da61d9f	2023-12-22	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36	OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE	ESTEE LAUDER INC	c670635a-63d8-4b0b-afd7-b26e969f93a1	2023-12-21	Warnings	Exact identifier application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutral	TITANIUM DIOXIDE	Tarte, Inc.	62fffef6-29ae-4137-b0b9-fb93d6167933	2023-12-21	Warnings	Exact identifier application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutral	TITANIUM DIOXIDE	Tarte, Inc.	889860fc-7fce-47e9-af28-a3b2aec04a0e	2023-12-21	Warnings	Exact identifier application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Ascendant Beauty LLC	cba4e886-c4c6-4377-8f4c-250aef4b95fb	2023-12-21	Warnings	Exact identifier application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	d12e30bd-88ee-4e34-ae63-c34766aed3a8	2023-12-20	Warnings	Exact identifier application number: M020
COOLA Liplux Hydrating Oil SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	2d2ad94c-ea13-43c0-ab7f-acecf4d2309f	2023-12-20	Warnings	Exact identifier application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70	TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%	COOLA LLC	a334a61d-5c5a-4f45-b202-6dd7bb3d250b	2023-12-20	Warnings	Exact identifier application number: M020
Bare Republic Big Adventure Stick SPF 70	TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%	COOLA	e800f72f-8c8b-4a12-843f-1ee404055cf0	2023-12-20	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