FDA.reportPublic FDA data

ORLASKIN HYDRATING SUNSCREEN SPF 50

Product NDC
87582-004
11-digit product format
875820004
Labeler code
87582
Product ID
87582-004_552b4c87-4622-d5a7-e063-6294a90a042e
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene Ethylhexyl Methoxycinnamate Ethylhexyl Salicylate Avobenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Guangzhou Yapheon Health Industry Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-27
Substance
OCTOCRYLENE; ETHYLHEXYL METHOXYCINNAMATE; ETHYLHEXYL SALICYLATE; AVOBENZONE
Active strength
10; 7; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL
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
ORLASKIN HYDRATING SUNSCREEN SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
ETHYLHEXYL METHOXYCINNAMATE7 g/100mL
ETHYLHEXYL SALICYLATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
552b4c87-4621-d5a7-e063-6294a90a042eAvailable on FDA.report

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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact identifier
application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15HOMOSALATE, OCTINOXATEFARMASI US LLC1dbd5e83-2248-4751-88d9-b446ccc3c61e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body SunAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC27fdbd2b-60de-4906-a176-5c5198d9925b2026-01-09WarningsExact identifier
application number: M020
Skin Metal StealthZINC OXIDESkin Metal47f5d7de-5d32-041a-e063-6394a90ab6f92026-01-09WarningsExact identifier
application number: M020
Salt and Blue Body Sunscreen SPF 30ZINC OXIDE 20%Salt + Blue LLC47f764a0-e9ad-ef66-e063-6394a90a8de52026-01-09WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENESupergoop, LLC61766f7b-512d-45b5-b652-e09975a3d3fc2026-01-09WarningsExact identifier
application number: M020
Defense Refresh (Re)Setting Mist SPF 40AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENESupergoop LLCb95ad8e3-978b-b721-e053-2a95a90a1e542026-01-09WarningsExact identifier
application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLCaed0dd03-1695-a5a9-e053-2995a90acfdc2026-01-09WarningsExact identifier
application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC972ebab9-3f2f-6716-e053-2a95a90a5c752026-01-09WarningsExact identifier
application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC972c68e7-b137-34c6-e053-2a95a90a77d62026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCee045b64-7a95-4378-8183-e6e556f3b1842026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC967d0657-18fc-4e4a-b52d-442df43329f12026-01-09WarningsExact identifier
application number: M020
PLAY SPF 30 Lip Shield CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0b8b850-bdfe-5563-e053-2995a90a51a72026-01-09WarningsExact identifier
application number: M020
Play SPF 30 Lip Shield StrawberryAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0a49142-53c3-5b7a-e053-2995a90a581d2026-01-09WarningsExact identifier
application number: M020
Glow Stick Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC61e543e3-9ace-6440-e053-2991aa0a96472026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf5c9801-26ce-5c60-e053-2995a90ab4572026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87582-004-0187582000401100 mL in 1 BOTTLE, SPRAY (87582-004-01) 100 ml2026-06-27NoNoCurrent