FDA.reportPublic FDA data

SUNSCREEN SPF50

Product NDC
85998-001
11-digit product format
859980001
Labeler code
85998
Product ID
85998-001_3bc1c6e9-1dd6-d7c6-e063-6394a90ad89e
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangzhou Tinsun Biotechnology Company Limited
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-07
Substance
OCTOCRYLENE; TITANIUM DIOXIDE; ETHYLHEXYL METHOXYCINNAMATE
Active strength
4; 2; 6 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
SUNSCREEN SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE4 g/100mL
TITANIUM DIOXIDE2 g/100mL
ETHYLHEXYL METHOXYCINNAMATE6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bc1c6e9-1dd5-d7c6-e063-6394a90ad89eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85998-001-01SUNSCREEN SPF5050 mL in 1 BOTTLECREAM501

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 84 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
(Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35ZINC OXIDESupergoop, LLCaed5a7ef-5cf2-6738-e053-2a95a90aa7f72026-01-09WarningsExact identifier
application number: M020
Play Mineral Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC89088ac5-f1ee-1996-e053-2a95a90a8fdc2026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf4b0f17-43ec-a176-e053-2a95a90a7ac62026-01-09WarningsExact identifier
application number: M020
(Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35ZINC OXIDESupergoop, LLCaf4cb85b-1275-2105-e053-2995a90a7e742026-01-09WarningsExact identifier
application number: M020
Play Lip Balm with Acai Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9f5b54c7-a424-6917-e053-2a95a90ac6272026-01-09WarningsExact identifier
application number: M020
Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESupergoop, LLC81b9fda2-bd55-1b90-e053-2991aa0a765a2026-01-09WarningsExact identifier
application number: M020
Play Lip Balm Broad Spectrum SPF 30 with MintAVOBENZONE, HOMOSALATE, OCTISALATE,Supergoop, LLC9f6cd243-ef5c-df8a-e053-2a95a90a4e362026-01-09WarningsExact identifier
application number: M020
Poolside Sun Silk Body Sunglow 05 Fragrance SPF 30 Sunscreen BodyHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLC4416ad39-a4b5-4238-9792-c7f475d1e5612026-01-09WarningsExact identifier
application number: M020
Lip Screen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCa3e5819a-5132-9760-e053-2a95a90a058b2026-01-09WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Scented SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCd96a1390-27be-452a-818b-0ba6127e9f962026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Daybreak Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLC4554d9a8-33a1-4299-8a57-dab72980b2eb2026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb5be8ea7-3408-4495-9a50-3328f76987382026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCc99464d1-a5bb-4140-a95e-25d6b383616c2026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Sunbeam Shimmer Sunscreen For the Face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLCf6316c4f-076a-4ba5-a526-0e20e5156ced2026-01-09WarningsExact identifier
application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1TITANIUM DIOXIDEAmway Corp4345cdf6-e220-4e7c-8abd-da59d2b7db842026-01-09WarningsExact identifier
application number: M020
Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30ZINC OXIDESupergoop LLCb47ed3bf-92a8-9bc9-e053-2a95a90a8eee2026-01-09WarningsExact identifier
application number: M020
Daily Dose Hydra-Ceramide Boost Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCca5520a1-4c43-cb32-e053-2a95a90a97f52026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85998-001-018599800010150 mL in 1 BOTTLE (85998-001-01) 50 ml2025-08-07NoNoCurrent