Broad Spectrum SPF45

Product NDC: 83286-008
11-digit product format: 832860008
Labeler code: 83286
Product ID: 83286-008_f6752fc2-97f8-4812-bd32-c91fb9b703be
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: 2025-04-08
Marketing end: 2027-04-30
Substance: ZINC OXIDE; OCTINOXATE
Active strength: 12; 7.5 g/100g; g/100g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
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

Active Ingredients#

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

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
ce93b371-26ab-4493-98e0-98234c3a9ba6	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
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
83286-008-01	Broad Spectrum SPF45	57 g in 1 BOTTLE	GEL	57		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83286-008	BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC]	2	Current NDC, 1 package rows	20250508_ce93b371-26ab-4493-98e0-98234c3a9ba6.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 283 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens SPF 50 Mineral Sunscreen	ZINC OXIDE	WALGREEN COMPANY	d50787f1-0c50-d153-e053-2995a90add1e	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens SPF55 Sunscreen Reef-Conscious Formula	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	cfd7c1b0-cfc3-074f-e053-2995a90a5edb	2024-10-14	Warnings	Exact identifier application number: M020
Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	WALGREEN COMPANY	dfc64c7b-ee59-62a3-e053-2995a90a14a1	2024-10-14	Warnings	Exact identifier application number: M020
WALGREENS SPORT CONTINUOUS SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	e4b84304-6053-0cfe-e053-2a95a90a124a	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 50 Baby Mineral Sunscreen	ZINC OXIDE	WALGREEN COMPANY	dbee6094-e105-6d14-e053-2995a90a1528	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF55 Sunscreen Reef-Conscious Formula	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	cfd6dd4c-21f6-7cef-e053-2a95a90a50e2	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF50 Sport Sunscreen Lip Balm Reef-Conscious Formula	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TARGET CORPORATION	f8c100bd-9230-813b-e053-6294a90ae006	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TARGET CORPORATION	cfd735d2-df3a-5ed0-e053-2995a90a9f26	2024-10-14	Warnings	Exact identifier application number: M020
Target Goodfellow and Co SPF 30 Face Scent No. 05 Kelp and Sea Mineral	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	f98ee294-3ca5-18bd-e053-6394a90a9aa5	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	f9027e42-017a-07fd-e053-6294a90ab916	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TARGET CORPORATION	f99028fa-a17e-4a84-e053-6294a90a927f	2024-10-14	Warnings	Exact identifier application number: M020
Up and Up Illuminating Daily Moisturizer with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE	TARGET CORPORATION	9407a4a9-8a72-6a01-e053-2a95a90a231d	2024-10-14	Warnings	Exact identifier application number: M020
Target Up and Up Morning Facial Moisturizing with Sunscreen Broad Spectrum SPF 30	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	TARGET CORPORATION	f9b66e3e-5493-9ea4-e053-6294a90a6063	2024-10-14	Warnings	Exact identifier application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SAFEWAY, INC.	a6296612-184c-6b3c-e053-2a95a90a34b9	2024-10-14	Warnings	Exact identifier application number: M020
OPEN NATURE SPF 50 MINERAL SUNSCREEN	ZINC OXIDE	SAFEWAY, INC.	a6020d2f-55c4-adfc-e053-2a95a90ad238	2024-10-14	Warnings	Exact identifier application number: M020
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN	ZINC OXIDE	SAFEWAY, INC.	a6044f0f-eb86-684d-e053-2995a90a0921	2024-10-14	Warnings	Exact identifier application number: M020
SIGNATURE CARE SPORT SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SAFEWAY, INC.	a62848fb-7016-3457-e053-2a95a90aa0f1	2024-10-14	Warnings	Exact identifier application number: M020
Safeway Signature Care Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Safeway, Inc.	c6a0ae3e-d68a-b838-e053-2a95a90a77f7	2024-10-14	Warnings	Exact identifier application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SAFEWAY, INC.	a628ff71-463d-4d39-e053-2995a90a7a42	2024-10-14	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Safeway, Inc.	c5106c63-af51-c169-e053-2a95a90afef2	2024-10-14	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	Marketing end	Sample	Exclude flag	Status
83286-008-01	83286000801	57 g in 1 BOTTLE (83286-008-01)	57 g	2025-04-08	2027-04-30	No	No	Historical