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
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3544916b-3f63-3a7a-e063-6394a90ae507Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85357-204-15Sun Therapy Sunscreen1.5 g in 1 PACKETCREAM1.52
85357-204-60Sun Therapy Sunscreen60 g in 1 BOTTLE, PUMPCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85357-204SUN THERAPY SUNSCREEN (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ]1Current NDC, 1 package rows20250521_357efafb-aa1c-0d69-e063-6394a90a5135.zip
85357-204SUN THERAPY SUNSCREEN (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ]1Current NDC, 1 package rows20250519_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 253 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLEOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29a8812b-70ff-e8aa-e063-6294a90a09f82024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.3a548deb-3670-4c5b-a139-796701801fed2024-12-19WarningsExact identifier
application number: M020
CLE CCC Olive Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.be4434c0-cbdd-46cb-8015-4c7859e80d4a2024-12-19WarningsExact identifier
application number: M020
CLE CCC Golden MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.de50e956-a014-4147-922b-63c95fa6f86b2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.44cbb226-83ed-401b-baf8-ca8e4740dbef2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.615f5e39-695d-41d4-af59-e0d3b76789bb2024-12-19WarningsExact identifier
application number: M020
CLE CCC Warm DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.6ab3e360-8104-4439-93fb-e11bc4a775582024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.a297ff64-678c-4936-8384-022606a2f33c2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a22024-12-19WarningsExact identifier
application number: M020
CLE CCC Cool Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.2e0365f9-d3c6-4404-90ac-772a829b3ade2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEGOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abae8f-53db-b592-e063-6294a90adabb2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29aba80c-55b7-b8d9-e063-6294a90a5cc12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abe97b-e9b3-6e27-e063-6294a90ae3ed2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDENOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abdf3c-fb54-a5e3-e063-6394a90af4502024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM FAIRZINC OXIDECOSMAX USA, CORPORATION29ac756b-3df7-50c9-e063-6394a90aa4792024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM RICHZINC OXIDECOSMAX USA, CORPORATION29ac51a0-07e7-ad7b-e063-6294a90ae7772024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPESTZINC OXIDECOSMAX USA, CORPORATION29ad12e2-0a2e-7138-e063-6394a90aebaf2024-12-19WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products, Inc.f2e34230-7bfb-455f-8b33-6bff96fd9f0a2024-12-19WarningsExact identifier
application number: M020
Anew Platinum DayCream Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONECOSMAX USA, CORPORATION56200212-bedc-6e1e-e063-6394a90a36662024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELLOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29868d60-b900-e0ad-e063-6294a90af87a2024-12-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85357-204-15853570204151.5 g in 1 PACKET (85357-204-15) 1.5 g2024-03-13YesNoCurrent
85357-204-608535702046060 g in 1 BOTTLE, PUMP (85357-204-60) 60 g2024-03-13NoNoCurrent