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 219 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear Sunscreen	HOMOSALATE, OCTISALATE AND OCTOCRYLENE	IT COSMETICS, LLC	9f8786cc-bef6-4449-8f31-dfc08de77734	2025-03-25	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All Shades	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b7d184fb-4a9a-4720-9b00-bf0caa257a8c	2025-03-25	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30cce5b1-ed41-5bf2-e063-6394a90aaf1d	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30df95da-4868-1414-e063-6294a90acdac	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e1bd3c-6a0b-a8f8-e063-6394a90acfb7	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e1b4c9-0d77-b08a-e063-6394a90af683	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e1ff3f-0fd0-2880-e063-6294a90a462f	2025-03-24	Warnings	Exact identifier application number: M020
KISS New York Tinted Moisturizer	ZINC OXIDE	IVY ENTERPRISES, INC.	30e25241-0d2b-8c04-e063-6294a90a44b9	2025-03-24	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Clear Complexion Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	311ae6d6-d466-3f1d-e063-6294a90ab3dd	2025-03-24	Warnings	Exact identifier application number: M020
DOMINAS DARK SPOT TINTED SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H CO., LTD.	2b6140cf-7e34-1658-e063-6394a90a3271	2025-03-24	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	311de9db-941c-5af9-e063-6294a90a3a13	2025-03-24	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Beach Guard Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	311e6378-5afa-d7eb-e063-6394a90a7728	2025-03-24	Warnings	Exact identifier application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100ml	NAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100ML	NAKED SUNDAYS PTY LTD	e182a39b-89b1-7756-e053-2a95a90ab619	2025-03-23	Warnings	Exact identifier application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM	AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,	NAKED SUNDAY PTY LTD	eb7a84a8-3e25-9988-e053-2a95a90a58a9	2025-03-23	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	01273e8c-aef0-d800-e063-6294a90abd49	2025-03-23	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	01221d57-9eec-7e77-e063-6394a90a6042	2025-03-23	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	0ce809a1-45fb-9d4d-e063-6294a90a26a2	2025-03-23	Warnings	Exact identifier application number: M020
GLOW BODY MIST SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	cba78484-3c0b-413e-e053-2995a90aad86	2025-03-23	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAM	ZINC OXIDE	ISNTREE Inc.	2a86be75-c0f3-a8a1-e063-6294a90a0448	2025-03-23	Warnings	Exact identifier application number: M020
SPF50 SHEER GLOW BALM ESPRESSO MARTINI 9g	ZINC OXIDE 22.75%	NAKED SUNDAY PTY LTD	fbfc1e74-139e-8b0d-e053-6394a90a97c5	2025-03-22	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