Tinted Mineral Sunscreen

Product NDC: 85366-204
11-digit product format: 853660204
Labeler code: 85366
Product ID: 85366-204_4614bcf0-8d3d-d59f-e063-6294a90ad265
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Gentlehomme LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-02
Substance: ZINC OXIDE
Active strength: 200 mg/g
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: Tinted Mineral Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

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
365e7d8e-e3e0-4c08-e063-6294a90af415	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85366-204-60	Tinted Mineral Sunscreen	60 g in 1 BOTTLE, PUMP	CREAM	60		2

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 285 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB SPF 50 Pomegranate Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b48729-43d3-72b4-e053-2995a90a9d85	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 For Men Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b682aa-a194-09ff-e053-2a95a90ade73	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Birthday Cake Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b755af-2bd3-33cf-e053-2a95a90a9961	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Watermelon Serbert Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f5b77cc0-1ed5-c4ae-e053-2a95a90abc1a	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6e0db20-594b-30a8-e053-6394a90a7164	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6dfe973-bd88-e0e4-e053-6394a90ac927	2024-10-15	Warnings	Exact identifier application number: M020
HEB Face Primer 30 Sunscreen Face Primer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H-E-B	f6e29c93-9fd9-36c6-e053-6394a90a1747	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	H.E.B.	c5279caf-3af9-d163-e053-2995a90a943b	2024-10-15	Warnings	Exact identifier application number: M020
HEB Face 50 Clear Zinc Sunscreen	OCTOCRYLENE, ZINC OXIDE	H.E.B.	f6e3c883-0087-dcd6-e053-6394a90a1272	2024-10-15	Warnings	Exact identifier application number: M020
HEB Mineral Sunscreen SPF 50	ZINC OXIDE	H.E.B.	de99343b-c74c-3f43-e053-2995a90ac9dd	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 55 Babies and Kids Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	f5660a97-57c8-61c7-e053-2995a90a0164	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B	SPF 50 SUNSCREEN	H.E.B	362f726b-d52b-4dae-ade6-a47de47697ef	2024-10-15	Warnings	Exact identifier application number: M020
HEB Sensitive 50 Mineral Sensitive Skin Sunscreen For Face	ZINC OXIDE	H.E.B.	dfb43fc5-4968-f999-e053-2a95a90a0819	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B BABY	SPF 50 SUNSCREEN	H.E.B	61273611-ab7a-4216-aebe-2c8d89660281	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B BANANA	SPF 50 SUNSCREEN	H.E.B	b9a9837a-094b-4a57-a50c-5c1437deda7b	2024-10-15	Warnings	Exact identifier application number: M020
HEB Solutions Sunscreen	SPORT SPF 100 LOTION	H.E.B	9e3ea66c-d6a0-49ca-a3c0-8175e0617453	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	ULTRA SPF 50 LOTION	H.E.B	12c76c72-4411-48d5-b79b-c58703bf1fdd	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	SPORT SPF 50 CONTINUOUS SPRAY	H.E.B	86ad5d30-f700-42a2-b810-dd2e3ed0f2d8	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B	SPF 50 SUNSCREEN	H.E.B	1f8d4f91-9eb9-41de-9066-a7a08c7ff84f	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	ULTRA SPF 100 CONTINUOUS SPRAY	H.E.B	be80244d-da6d-4d37-b228-4d3fac335caf	2024-10-15	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
85366-204-60	85366020460	60 g in 1 BOTTLE, PUMP (85366-204-60)	60 g	2023-05-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Mineral Sunscreen	Gentlehomme LLC \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-16	HUMAN OTC DRUG LABEL	2