Broad Spectrum SPF45

Product NDC: 83286-014
11-digit product format: 832860014
Labeler code: 83286
Product ID: 83286-014_4f1a74ff-5ef6-4174-bb9b-b3ade1dc4f9c
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Octinoxate
Dosage form: GEL
Route: TOPICAL
Labeler: Drmtlgy, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-05-01
Substance: ZINC OXIDE; OCTINOXATE
Active strength: 12; 7.5 g/100mL; g/100mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: Broad Spectrum SPF45
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	12 g/100mL
OCTINOXATE	7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	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
0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83286-014-01	Broad Spectrum SPF45	50 mL in 1 BOTTLE	GEL	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83286-014	BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC]	1	Current NDC, 1 package rows	20250508_0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8.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 315 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30	AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE	Flageoli Limited	4d11cc46-3942-1561-e054-00144ff8d46c	2023-12-12	Warnings	Exact identifier application number: M020
ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX	ZINC OXIDE	SIBORG LLC	9c4897f8-8fcb-4a0f-b42e-f582e2934f02	2023-12-12	Warnings	Exact identifier application number: M020
Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	ENGLEWOOD LAB, INC.	f63fe60f-9863-1dfb-e053-2a95a90a90a5	2023-12-12	Warnings	Exact identifier application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	5742da4b-6713-4de9-8ab8-b2bf2983371a	2023-12-12	Warnings	Exact identifier application number: M020
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex	ZINC OXIDE	RESTORSEA INC	80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a	2023-12-12	Warnings	Exact identifier application number: M020
ReVive Fermitif Neck Renewal SPF 15	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE	Gurwitch Products, LLC	de54d4ff-f9b4-4a12-95ea-fc2b61bee1c3	2023-12-12		Exact identifier application number: M020
Laura Mercier Flawless Skin Daily Face Shield SPF 40	OCTINOXATE, TITANIUM DIOXIDE	Gurwitch Products, LLC	f86729cd-682f-47b2-9bfa-1113721bfec0	2023-12-12	Warnings	Exact identifier application number: M020
Boscia BB SPF 27 PA	TITANIUM DIOXIDE	Boscia LLC	5dc86c0b-c340-4643-a174-a6b4c0826ca9	2023-12-12	Warnings	Exact identifier application number: M020
Dr.Denese SPF 30 Defense Day	ZINC OXIDE, OCTINOXATE	SkinScience Labs, Inc	511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa	2023-12-12	Warnings	Exact identifier application number: M020
Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily Skin	AVOBENZONE, OCTINOXATE	Boscia LLC	0c987cb9-7049-44b9-9935-647b0411a734	2023-12-12	Warnings	Exact identifier application number: M020
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	82a23aab-404f-46bb-afaa-8ba9b9bdbefd	2023-12-12	Warnings	Exact identifier application number: M020
Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry Skin	AVOBENZONE, OCTINOXATE	Boscia LLC	657b04c6-d15b-470b-92e6-e59ed7e8b116	2023-12-12	Warnings	Exact identifier application number: M020
Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	Market America	c1898e00-05f1-4e28-9fa8-8cda1b178595	2023-12-12	Warnings	Exact identifier application number: M020
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting Shade	TITANIUM DIOXIDE, ZINC OXIDE	Boscia LLC	5f5fb9f5-00be-420a-b19a-b753c45f9a88	2023-12-12	Warnings	Exact identifier application number: M020
Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE	Boscia LLC	7d948951-598a-4a38-94a2-d357ee7f4d1e	2023-12-12	Warnings	Exact identifier application number: M020
Restorative Day Moisture SPF 15	OCTINOXATE, AVOBENZONE	Boscia LLC	01f17133-7f29-4f8e-a52c-c4466e4abefc	2023-12-12	Warnings	Exact identifier application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03	TITANIUM DIOXIDE	3LAB, Inc.	8a42a9d8-b9c6-45fb-8264-15f36e2765f0	2023-12-12	Warnings	Exact identifier application number: M020
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen	OCTINOXATE, OCTISALATE, AVOBENZONE	3LAB, Inc	d539b851-c4b2-40a2-9562-e3a95a86b744	2023-12-12	Warnings	Exact identifier application number: M020
3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	3LAB, Inc	3052af3f-8923-47bc-be6e-17396275363a	2023-12-12	Warnings	Exact identifier application number: M020
Isa SunGuard SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	Isagenix International, LLC	abe1e345-6ea2-43b3-8613-b5b5e04c87b7	2023-12-12	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83286-014-01	83286001401	50 mL in 1 BOTTLE (83286-014-01)	50 ml	2025-05-01	No	No	Current