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 344 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	96437795-906f-4e11-ac69-c0c2ae264aae	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cashew	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b5527aba-5856-44cd-a1d5-f2d7cefb45ea	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9b641ccb-3046-4b21-8164-b80813090cb4	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2500fe73-00e2-47ba-9e2b-1c268ed4a9e6	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	4df1b021-5028-456e-87f2-a96ea6c26c7b	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	830a485c-53d4-4fa9-b0cd-0fd2a9bd234b	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8a9fe755-32a2-49b0-8c78-f84bd2ba148f	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c5f3f1bc-adca-495f-b1bc-51c91d42a480	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Uber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	64db3a1f-d6c7-4766-a52c-a4b0c39e2633	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Walnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	582a8244-dab8-4861-9115-2e895a586fb9	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deeply Bronze	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	377405a6-b6c6-4afb-9270-73d933029054	2021-07-13	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9f7c8d53-6549-4bac-bbae-a2b73fdf6b05	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	5a22b123-9077-4b8a-ac4c-1bdd475c6ac3	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Calico	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	4647828c-661d-4ebe-b27e-13d8b89647b8	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	c82f36da-16ce-45f4-9786-2026a359060a	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Wheat	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	3d86dca5-9e33-4284-a4c1-f5eed64b0620	2021-07-12	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Willow	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	0489a046-2173-4137-abff-c6a7cdb5e8fd	2021-07-12	Warnings	Exact identifier application number: M020
H.E.B. Solutions Sunscreen	SPORT SPF 70 LOTION	H.E.B	00cade74-9a8f-4af9-a809-ebf0ff2bbc3c	2021-07-09	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	KIDS SPF 70 LOTION	H.E.B	9f08c40e-b5c6-4ca4-8c24-0a0f98787217	2021-07-09	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	SPORT SPF 50 LOTION	H.E.B	6e45677e-1066-498e-b423-109a94a152aa	2021-07-09	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