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 239 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sheglam Dew and Done Skin Tint with SPF 20 Nude	ZINC OXIDE	EVER FAME PTE. LTD.	2abd8527-72a5-1564-e063-6294a90ad8d3	2025-01-02	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Nutmeg	ZINC OXIDE	EVER FAME PTE. LTD.	2abdda5e-0f52-ae46-e063-6394a90ae6f5	2025-01-02	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Porcelain	ZINC OXIDE	EVER FAME PTE. LTD.	2abdddbc-d891-7c4d-e063-6294a90a8162	2025-01-02	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Russet	ZINC OXIDE	EVER FAME PTE. LTD.	2abe084b-7478-e923-e063-6394a90ac941	2025-01-02	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Peach	ZINC OXIDE	EVER FAME PTE. LTD.	2abdca50-ffc4-8c36-e063-6394a90af766	2025-01-02	Warnings	Exact identifier application number: M020
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	c3bacceb-63a8-098c-e053-2995a90acd64	2025-01-02	Warnings	Exact identifier application number: M020
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16	ZINC OXIDE	REJUVA MINERALS INC	3d83c220-1801-4193-b6a8-c777f412c173	2025-01-02	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Saddle	ZINC OXIDE	EVER FAME PTE. LTD.	2abf69c5-07d7-252d-e063-6394a90a292b	2025-01-02	Warnings	Exact identifier application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Sand	ZINC OXIDE	EVER FAME PTE. LTD.	2abf7869-4418-7738-e063-6394a90ae89d	2025-01-02	Warnings	Exact identifier application number: M020
Good Weather Skin The One Daily Sun SPF 30	ZINC OXIDE	Good Weather Inc.	2ac30544-5ece-18ed-e063-6394a90a6a0d	2025-01-02	Warnings	Exact identifier application number: M020
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plus	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Exelencia importers Corp.	283c2780-5ad5-38f1-e063-6294a90ac336	2025-01-01	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Biocosmetica Exel Argentina SRL	2aabf782-65f9-e894-e063-6394a90a1ea3	2025-01-01	Warnings	Exact identifier application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS	OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE	Biocosmetica Exel Argentina SRL	2aad5b97-e64b-c678-e063-6294a90aa8c6	2025-01-01	Warnings	Exact identifier application number: M020
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45	AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	KONAD CO LTD	2aafbd33-710a-201e-e063-6294a90ab1bb	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30ac897-3a30-7bba-e053-2995a90ac342	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30b0588-b0f4-39a8-e053-2a95a90abb35	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30aeaa6-3423-401c-e053-2a95a90a8fe9	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige	ENSULIZOLE, TITANIUM DIOXIDE	fmg Co.Ltd	d30afd94-8bcd-01bc-e053-2a95a90afb49	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d30b156a-b9b1-499b-e053-2a95a90ada6a	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d30b183d-a54d-752c-e053-2a95a90a24fc	2025-01-01	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