FDA.reportPublic FDA data

Purpose Dual Treatment SPF 10

Product NDC
87033-2000
11-digit product format
870332000
Labeler code
87033
Product ID
87033-2000_3d7fe711-a672-df30-e063-6394a90afbbf
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate 7.5%, Octisalate 5%, Oxybenzone 3%
Dosage form
LOTION
Route
TOPICAL
Labeler
Elysium Consumer Healthcare LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-29
Substance
OXYBENZONE; OCTINOXATE; OCTISALATE
Active strength
3; 7.5; 5 g/100g; g/100g; g/100g
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
Purpose Dual Treatment SPF 10
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE3 g/100g
OCTINOXATE7.5 g/100g
OCTISALATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95OOS7VE0YInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d7fe711-a671-df30-e063-6394a90afbbfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87033-2000-1Purpose Dual Treatment SPF 101 in 1 CARTONLOTION11
87033-2000-1Purpose Dual Treatment SPF 10113 g in 1 BOTTLE, PLASTICLOTION1131

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 NudeZINC OXIDEEVER FAME PTE. LTD.2abd8527-72a5-1564-e063-6294a90ad8d32025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 NutmegZINC OXIDEEVER FAME PTE. LTD.2abdda5e-0f52-ae46-e063-6394a90ae6f52025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PorcelainZINC OXIDEEVER FAME PTE. LTD.2abdddbc-d891-7c4d-e063-6294a90a81622025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 RussetZINC OXIDEEVER FAME PTE. LTD.2abe084b-7478-e923-e063-6394a90ac9412025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PeachZINC OXIDEEVER FAME PTE. LTD.2abdca50-ffc4-8c36-e063-6394a90af7662025-01-02WarningsExact identifier
application number: M020
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3bacceb-63a8-098c-e053-2995a90acd642025-01-02WarningsExact identifier
application number: M020
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16ZINC OXIDEREJUVA MINERALS INC3d83c220-1801-4193-b6a8-c777f412c1732025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SaddleZINC OXIDEEVER FAME PTE. LTD.2abf69c5-07d7-252d-e063-6394a90a292b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandZINC OXIDEEVER FAME PTE. LTD.2abf7869-4418-7738-e063-6394a90ae89d2025-01-02WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun SPF 30ZINC OXIDEGood Weather Inc.2ac30544-5ece-18ed-e063-6394a90a6a0d2025-01-02WarningsExact identifier
application number: M020
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aad5b97-e64b-c678-e063-6294a90aa8c62025-01-01WarningsExact identifier
application number: M020
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEKONAD CO LTD2aafbd33-710a-201e-e063-6294a90ab1bb2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30ac897-3a30-7bba-e053-2995a90ac3422025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30b0588-b0f4-39a8-e053-2a95a90abb352025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30aeaa6-3423-401c-e053-2a95a90a8fe92025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30afd94-8bcd-01bc-e053-2a95a90afb492025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b156a-b9b1-499b-e053-2a95a90ada6a2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b183d-a54d-752c-e053-2a95a90a24fc2025-01-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87033-2000-1870332000011 BOTTLE, PLASTIC in 1 CARTON (87033-2000-1) / 113 g in 1 BOTTLE, PLASTIC2025-08-29NoNoCurrent