Sun Therapy Sunscreen

Product NDC: 85357-204
11-digit product format: 853570204
Labeler code: 85357
Product ID: 85357-204_46002963-21ee-887d-e063-6394a90a3a9a
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Skin Therapy Studio LLC�
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-13
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: Sun Therapy 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
3544916b-3f63-3a7a-e063-6394a90ae507	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85357-204-15	Sun Therapy Sunscreen	1.5 g in 1 PACKET	CREAM	1.5		2
85357-204-60	Sun Therapy Sunscreen	60 g in 1 BOTTLE, PUMP	CREAM	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85357-204	SUN THERAPY SUNSCREEN (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ]	1	Current NDC, 1 package rows	20250521_357efafb-aa1c-0d69-e063-6394a90a5135.zip
85357-204	SUN THERAPY SUNSCREEN (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ]	1	Current NDC, 1 package rows	20250519_3544916b-3f63-3a7a-e063-6394a90ae507.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 209 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT	Pacifica Beauty, LLC	373aba7c-2ae1-8726-e063-6294a90ae3d8	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM	Pacifica Beauty, LLC	373c29b9-2f75-9777-e063-6394a90a68a6	2025-06-10	Warnings	Exact identifier application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, AND HOMOSALATE	MDSolarSciences	374395ea-ab91-de70-e063-6394a90aec56	2025-06-10	Warnings	Exact identifier application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30	ZINC OXIDE	Andalou naturals	aa689e82-6512-46d8-aec9-269f9348d3f8	2025-06-09	Warnings	Exact identifier application number: M020
ALLIES OF SKIN The One SPF-50 Invisible Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	ALLIES GROUP PTE. LTD.	36e1c61c-33ab-4a5d-853d-119c29632b08	2025-06-09	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTION S	TITANIUM DIOXIDE AND ZINC OXIDE	Shiseido Americas Corporation	b2fae1ba-67fe-48ef-b31f-62db34349961	2025-06-09	Warnings	Exact identifier application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	372819f1-0813-2cd5-e063-6294a90ac5bf	2025-06-09	Warnings	Exact identifier application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-Clear	AVOBENZONE, HOMOSALATE, OCTISALATE	e.l.f. Cosmetics, Inc.	3806e2f2-ffd1-6d69-e063-6394a90acb44	2025-06-09	Warnings	Exact identifier application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-Getaway	AVOBENZONE, HOMOSALATE, OCTISALATE	e.l.f. Cosmetics, Inc.	3808613f-88d6-6c1a-e063-6294a90a5bb2	2025-06-09	Warnings	Exact identifier application number: M020
1000 Roses Daily Shade Facial SPF 18	OCTISALATE, OCTOCRYLENE, AND AVOBENZONE	Andalou naturals	0923e090-6834-4373-80fe-21f00b8c1c17	2025-06-09	Warnings	Exact identifier application number: M020
dAlba Vegan Fresh Sun Cushion	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE	ADMTMAX LLC	20afcbab-a2f4-7965-e063-6294a90a83d1	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Mild Sunscreen	ZINC OXIDE	ADMTMAX LLC	20ab5698-cd9f-0821-e063-6394a90a60d7	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Fresh Sun Stick	HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE	ADMTMAX LLC	20ae82ae-bc8f-89d1-e063-6394a90afff2	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Essence Sunscreen	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE	ADMTMAX LLC	1ccfa213-2f83-ad50-e063-6294a90a38bf	2025-06-08	Warnings	Exact identifier application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium	ZINC OXIDE	Pacifica Beauty, LLC	36ec6c9d-f7dc-0419-e063-6294a90a55e6	2025-06-06	Warnings	Exact identifier application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair	ZINC OXIDE	Pacifica Beauty, LLC	36ed9101-249a-922c-e063-6394a90a2608	2025-06-06	Warnings	Exact identifier application number: M020
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields Beauty, LLC	afa2d42e-b54d-4843-b313-0c44fe5c5d52	2025-06-06	Warnings	Exact identifier application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30	ZINC OXIDE	Andalou naturals	9314e4fc-ba3e-480e-a005-b8928130ed70	2025-06-06	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac	2025-06-05	Warnings	Exact identifier application number: M020
Body Glove Sunscreen SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	SCUBASCREEN LLC	1d7a960c-4387-44dc-8d4e-881e21a8ae2e	2025-06-05	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
85357-204-15	85357020415	1.5 g in 1 PACKET (85357-204-15)	1.5 g	2024-03-13	Yes	No	Current
85357-204-60	85357020460	60 g in 1 BOTTLE, PUMP (85357-204-60)	60 g	2024-03-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sun Therapy Sunscreen	Skin Therapy Studio LLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2
Sun Therapy Sunscreen	Skin Therapy Studio LLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2