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 339 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Peppermint SPF 15 Broad Spectrum Lip Balm	PEPPERMINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a901a7f7-af83-0aa1-e053-2995a90aa32b	2023-10-18	Warnings	Exact identifier application number: M020
Mineral SPF 15 Broad Spectrum Lip Balm	MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	44d2759a-d95d-7525-e054-00144ff88e88	2023-10-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d	2023-10-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	d60887aa-7586-4d4b-88af-35b4f982aacf	2023-10-18	Warnings	Exact identifier application number: M020
JESS BEAUTY Sun Drops Protection SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	d13da7be-a419-4416-96be-8421665dbd82	2023-10-17	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALM	Raining Rose	efe27e7e-e805-1c47-e053-2995a90af22e	2023-10-17	Warnings	Exact identifier application number: M020
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	f1109f0e-ebf5-450e-8a4e-b314a91b2483	2023-10-13	Warnings	Exact identifier application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN FACE WITH SOLAR SMART	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	8c7c0e3f-6092-413c-90f1-b3466c8a9501	2023-10-13	Warnings	Exact identifier application number: M020
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar Smart	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	3d23406b-5252-4ab0-b666-77c0132b0d00	2023-10-13	Warnings	Exact identifier application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	94274343-3892-4c27-9d2f-c025310e2959	2023-10-13	Warnings	Exact identifier application number: M020
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	e557e7f3-1fa7-4dde-977f-fe3f942496c0	2023-10-13	Warnings	Exact identifier application number: M020
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	68cfcbc2-a214-437e-9956-f77c90d74888	2023-10-13	Warnings	Exact identifier application number: M020
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	159410d4-4479-4442-b371-bde72aae3e1e	2023-10-13	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection	HOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE	Laboratoires Clarins	0695e3a4-0e8f-419e-b128-9b02bdb8b02a	2023-10-11	Warnings	Exact identifier application number: M020
Orange Soda SPF 15 Broad Spectrum Lip Balm	ORANGE SODA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a0c362ae-b878-c630-e053-2995a90ad4c4	2023-10-10	Warnings	Exact identifier application number: M020
Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVB	ZINC OXIDE	Skin Laundry Holdings, Inc.	071038d9-8179-6953-e063-6394a90a8a84	2023-10-06	Warnings	Exact identifier application number: M020
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	4bae83b7-2c98-4928-8e71-bb4f19cc48f0	2023-10-05	Warnings	Exact identifier application number: M020
BB Broad Spectrum SPF 15 Light	ZINC OXIDE TITANIUM DIOXIDE	Burt's Bees	3150ef71-2ea1-25d0-e054-00144ff88e88	2023-10-05	Warnings	Exact identifier application number: M020
BB Broad Spectrum SPF 15 Medium	ZINC OXIDE TITANIUM DIOXIDE	Burt's Bees	3346f41e-32d0-35d0-e054-00144ff88e88	2023-10-05	Warnings	Exact identifier application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	59eeb180-1ac6-44b3-9742-dc65287896bf	2023-10-05	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