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 257 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLE CCC Neutral Medium Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	615f5e39-695d-41d4-af59-e0d3b76789bb	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Warm Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE	KW ABSC, INC.	6ab3e360-8104-4439-93fb-e11bc4a77558	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	a297ff64-678c-4936-8384-022606a2f33c	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Neutral Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2	2024-12-19	Warnings	Exact identifier application number: M020
CLE CCC Cool Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	2e0365f9-d3c6-4404-90ac-772a829b3ade	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEG	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abae8f-53db-b592-e063-6294a90adabb	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29aba80c-55b7-b8d9-e063-6294a90a5cc1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abe97b-e9b3-6e27-e063-6294a90ae3ed	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDEN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abdf3c-fb54-a5e3-e063-6394a90af450	2024-12-19	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM FAIR	ZINC OXIDE	COSMAX USA, CORPORATION	29ac756b-3df7-50c9-e063-6394a90aa479	2024-12-19	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM RICH	ZINC OXIDE	COSMAX USA, CORPORATION	29ac51a0-07e7-ad7b-e063-6294a90ae777	2024-12-19	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPEST	ZINC OXIDE	COSMAX USA, CORPORATION	29ad12e2-0a2e-7138-e063-6394a90aebaf	2024-12-19	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products, Inc.	f2e34230-7bfb-455f-8b33-6bff96fd9f0a	2024-12-19	Warnings	Exact identifier application number: M020
Anew Platinum DayCream Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	COSMAX USA, CORPORATION	56200212-bedc-6e1e-e063-6394a90a3666	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29868d60-b900-e0ad-e063-6294a90af87a	2024-12-18	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM	ZINC OXIDE	COSMAX USA, CORPORATION	298707d4-72ed-796f-e063-6294a90aa5cd	2024-12-18	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT	ZINC OXIDE	COSMAX USA, CORPORATION	29871c02-9adf-6266-e063-6394a90a20ab	2024-12-18	Warnings	Exact identifier application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM TAN	ZINC OXIDE	COSMAX USA, CORPORATION	29874029-24bf-b2ce-e063-6394a90acd4d	2024-12-18	Warnings	Exact identifier application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30	ZINC OXIDE	Babo Botanicals, Inc.	2990e4ff-5bdb-3008-e063-6294a90a9497	2024-12-18	Warnings	Exact identifier application number: M020
Tinted Lip Cream SPF 15	ZINC OXIDE	COSMAX USA, CORPORATION	29915354-4673-7444-e063-6294a90a0fd1	2024-12-18	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