FDA.reportPublic FDA data

Homosalate 10 Avobenzone 3% Octocrylene 6%

Product NDC
87170-003
11-digit product format
871700003
Labeler code
87170
Product ID
87170-003_4951b0e0-e27f-b649-e063-6394a90acc11
Type
HUMAN OTC DRUG
Nonproprietary name
SPF 45 Face
Dosage form
LOTION
Route
TOPICAL
Labeler
S&C Hampton Sun LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
6; 10; 3 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
Homosalate 10 Avobenzone 3% Octocrylene 6%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE6 g/100mL
HOMOSALATE10 g/100mL
AVOBENZONE3 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
V06SV4M95SInternal 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
e49808c9-5025-4965-8679-7fe824cf6907Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87170-003-01Homosalate 10 Avobenzone 3% Octocrylene 6%20 mL in 1 TUBELOTION203
87170-003-02Homosalate 10 Avobenzone 3% Octocrylene 6%59 mL in 1 TUBELOTION593

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 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nu Skin 180 Degree UV Defense Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc91a22a5a-87fd-4db0-9183-caebee4013042024-12-24WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incaefd7884-6bc3-4b0b-ba36-1f3e8fe49f932024-12-23WarningsExact identifier
application number: M020
Attitude mineral sunscreen tropical SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude56e57ca0-d163-4580-9bca-747acce4d69f2024-12-23WarningsExact identifier
application number: M020
(S)UNDERCOVER SPF 50ZINC OXIDETUBBY TODDdca478a0-c319-68d8-e053-2a95a90a10fc2024-12-23WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Ince7bef1da-ea35-4306-b043-73d566a7e6bb2024-12-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc46aa9917-52ac-4c57-afde-366d2d3ca2002024-12-23WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1d115945-fa1b-485b-bf53-44308fd1a6302024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATEL'Oreal USA Products Inc7cc920de-c91f-4040-a0b9-ea216d6f9bd72024-12-23WarningsExact identifier
application number: M020
Kids SPF50Plus Mineral Sunscreen Rollerball Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd3bdda65-bcb4-42d9-84af-d14c7f4421bd2024-12-23WarningsExact identifier
application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin ProtectantDIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Ince8539a43-db85-451c-bce8-2c488f3dc40d2024-12-23WarningsExact identifier
application number: M020
NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE,OCTISALATE AND OCTOCRYLENELOreal USA Products Inc81093d80-dcaf-4555-98b2-48ce7eb84d0c2024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATESICOS ET CIEc634eaab-f014-4155-a40b-9030e358ec122024-12-23WarningsExact identifier
application number: M020
Kids SPF50 Plus Mineral Sunscreen Continuous Totally TropicalZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanicsd5ffe993-de8f-4623-a010-9cb8dd70de072024-12-23WarningsExact identifier
application number: M020
CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc8b298516-70df-47ab-834f-51dcde28a43a2024-12-23WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE6a14ee23-28c9-4704-8af9-d1c4db0d92562024-12-23WarningsExact identifier
application number: M020
Walgreens SPF 50 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf347588d-8225-45a7-e053-2995a90ab6882024-12-22WarningsExact identifier
application number: M020
Mineral SunstickZINC SPF STICKTubby Todd29e41fe8-4e17-dbaa-e063-6294a90a4a102024-12-22WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50Tubby Todd29e487da-5312-8192-e063-6294a90ad8092024-12-22WarningsExact identifier
application number: M020
EcoStick Sunscreen SPF 35ZINC OXIDE, TITANIUM DIOXIDEStream2Sea, LLCeba17b7a-5e96-4462-9b71-44c2bc577dce2024-12-21WarningsExact identifier
application number: M020
Planet Protecting Sunscreen 30TITANIUM DIOXIDEStream2Sea, LLC89e44c5f-121e-4fdd-b9e0-023909ea32f52024-12-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87170-003-018717000030120 mL in 1 TUBE (87170-003-01) 20 ml2024-01-15NoNoCurrent
87170-003-028717000030259 mL in 1 TUBE (87170-003-02) 59 ml2024-01-15NoNoCurrent