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 76 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	824c5f13-970e-4e9e-8f2a-2a01973d2e59	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7621ef5-47fc-4ccc-aedd-eac328ace7b9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	64a29ff8-e24d-4818-9b54-734a0eb2a13f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17a0201b-b797-4e65-838f-1ce8d408a020	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72e2c71a-da1d-497f-a8b7-491cff951c63	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	19d1432a-96b0-4cef-b13e-895dd41b41d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a06c820-ccd8-47ce-8bbf-7e90da92b1de	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	205e195a-fd30-44f7-9294-e701f0f766d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5495ff75-0c83-4491-8af7-4aed7a779d7f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	10bc345d-a5b1-4b70-bfa6-a2d7816904bf	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	30268b6e-d42a-4314-b82f-24f9e81cca2a	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	545c962f-2a59-4d94-8fef-ebdba4127f42	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17c9226b-459c-42fe-ac50-7e26db6b49af	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bf323e10-5479-44b3-b4b9-b8ca6b0f7688	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d6a5133-b847-4ecf-8c33-1cb05aca6b91	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	275be888-2c52-43ed-846a-55525002edcd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c73576a6-dbab-4205-add5-876a060b5022	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ae761ac-df06-4913-a8bf-8ca1be32b5b7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72c45120-6997-4250-b9b4-1cdb762efe1a	2026-01-16	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