Sun Therapy Sunscreen

Product NDC: 85357-204
Requested package NDC: 85357-204-60
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 179 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff	ZINC OXIDE	Cosmetic Enterprises Ltd	265bc5e0-0a2a-842e-e063-6394a90aae0a	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha	ZINC OXIDE	Cosmetic Enterprises Ltd	2748b6bc-e80b-ce66-e063-6394a90a400a	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze	ZINC OXIDE	Cosmetic Enterprises Ltd	265bf123-c4c3-8414-e063-6394a90a4730	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory	ZINC OXIDE	Cosmetic Enterprises Ltd	2748c351-0a7d-6913-e063-6394a90a6ef2	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude	ZINC OXIDE	Cosmetic Enterprises Ltd	265bd73f-2509-90c6-e063-6294a90a2e19	2025-10-13	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	dad4b244-2d34-40cb-88dc-991358df83b0	2025-10-10	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eafc00ce-12e7-921f-e053-2995a90a241a	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d0294b-e937-336d-e063-6294a90a5c3c	2025-10-10	Warnings	Exact identifier application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	b6c316c3-661b-6428-e053-2a95a90a1a6b	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d15366-85b8-f5e8-e063-6294a90a5fd8	2025-10-10	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4369f2f-fdc3-e48e-e053-2995a90a07f7	2025-10-10	Warnings	Exact identifier application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4ac746a-a50a-8041-e053-2a95a90a8ea6	2025-10-10	Warnings	Exact identifier application number: M020
Wonderscreen Broad Spectrum SPF 30	ZINC OXIDE	Wasatch Product Development, LLC.	e895d942-e50e-1ad6-e053-2995a90a0e02	2025-10-10	Warnings	Exact identifier application number: M020
Illuminating SPF 50 plus drops Broad Spectrum Sunscreen	ZINC OXIDE	Cosmetic Enterprise Ltd	13f40485-b98e-e804-e063-6394a90af2af	2025-10-10	Warnings	Exact identifier application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Cosmetic Enterprises LTD	a84d246b-1153-85ff-e053-2995a90a270a	2025-10-10	Warnings	Exact identifier application number: M020
MediChoice Moisturizing Lip Balm SPF15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	O&M HALYARD, INC.	00327815-28f0-4198-bca7-c8ae768ff416	2025-10-09	Warnings	Exact identifier application number: M020
Daybird 4-in-1 Skin Tint Serum	ZINC OXIDE	Resette, Inc.	19c1a934-b0f5-1068-e063-6294a90a3b1f	2025-10-09	Warnings	Exact identifier application number: M020
pavise Lip Defense tinted hydrating oil (hue 604)	ZINC OXIDE	B.A.I. Biosciences INC.	f4ebbc1d-d521-1a47-e053-2a95a90a6f84	2025-10-09	Warnings	Exact identifier application number: M020
pavise Lip Defense tinted hydrating oil (hue 774)	ZINC OXIDE	B.A.I. Biosciences INC.	f4ebd850-11a8-0d43-e053-2a95a90a2d34	2025-10-09	Warnings	Exact identifier application number: M020
pavise Lip Defense tinted hydrating oil (hue 616)	ZINC OXIDE	B.A.I. Biosciences INC.	f4eb6b20-7c26-2942-e053-2a95a90abd31	2025-10-09	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
85357-204-60	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