SPF 30 Mineral Sunscreen

Product NDC: 83369-003
11-digit product format: 833690003
Labeler code: 83369
Product ID: 83369-003_4c25b4ec-b046-7066-e063-6294a90ab801
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Smalls Brand LLC DBA Roe Wellness
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-03-03
Substance: ZINC OXIDE
Active strength: 19 g/100g
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: SPF 30 Mineral Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	19 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
4c25b4ec-b045-7066-e063-6294a90ab801	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83369-003-01	SPF 30 Mineral Sunscreen	50 g in 1 CARTON	CREAM	50		1

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 104 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6da72e20-f2d7-492e-9b65-b5ac73bc0029	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	de615c3e-669f-493c-9c75-73dfbe726c59	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	152790ba-aeda-4c2a-b725-7e040e832883	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c87e5201-f7fd-4fd9-adeb-d6af9be00db6	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84cdaad2-5b7d-4841-bef6-ffad4fe6907a	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b4caa2bc-8118-4137-8834-25800f8e5e01	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c0fa32fe-faa7-4a47-906c-14db01e55d47	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ff1a8b32-c01f-4910-9a7a-c74eb49c05a0	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d3bd710b-7d1a-4f96-9fbc-a67c550d863b	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	3b6ea0ec-4636-43cf-a324-a82666108e95	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ac7fb96-a2f2-4086-82ad-c45d7a709091	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84a5f7e1-1c04-43cd-8d3b-60c7e2418faf	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28a61b11-5901-47ec-916c-e2ae4f79a11d	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ddf8221-9bfc-4c52-9a51-a0d725b7a23e	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5937248a-b96e-490a-9f93-10e65969ac10	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	62136c4c-6f05-4de0-a71e-55aa53160685	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a8037741-ec57-43e7-adb4-2a93941ee108	2025-12-19	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83369-003-01	83369000301	50 g in 1 CARTON (83369-003-01)	50 g	2026-03-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Roe Wellness SPF 30 Mineral Sunscreen	Smalls Brand LLC DBA Roe Wellness	2026-03-03	HUMAN OTC DRUG LABEL	1