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 181 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciele Bronze and ProtectZINC OXIDECiele LLC22003cbf-5a6d-001b-e063-6394a90aefdd2025-10-15WarningsExact identifier
application number: M020
Ciele Blush and ProtectZINC OXIDECiele0162c891-ba2d-a78f-e063-6394a90a156c2025-10-15WarningsExact identifier
application number: M020
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
application number: M020
Ciele Sculpt and ProtectZINC OXIDECiele LLC21ff7f78-b543-0bea-e063-6294a90aed702025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREENZINC OXIDELather, Inc.3158a2d7-0db5-f5bf-e063-6294a90a31262025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50ZINC OXIDELather, Inc.81cf57b0-6072-432f-b421-7d1a708da1c42025-10-15WarningsExact identifier
application number: M020
Ciele Glow and ProtectZINC OXIDECiele Cosmetics27310d47-de1b-2149-e063-6394a90abe832025-10-15WarningsExact identifier
application number: M020
Sunforgettable Total Protection Sport StickZINC OXIDEColorescienced3c0d2b0-f411-565d-e053-2a95a90a081b2025-10-15WarningsExact identifier
application number: M020
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE HOMOSALATE OCTOCRYLENEEdgewell Personal Care Brands LLC41376da3-5274-b133-e063-6394a90afa132025-10-15WarningsExact identifier
application number: M020
Curology Daily Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECurologyee59d52e-5dc6-4fb4-96d8-0bda40e230092025-10-15WarningsExact identifier
application number: M020
SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSETZINC OXIDEColoresciencef4aa14ed-6c6f-8301-e053-2a95a90a5e232025-10-15WarningsExact identifier
application number: M020
Curology The Lip Balm Broad Spectrum SPF 30 SunscreenZINC OXIDECurology Inc.e441b13f-cb58-457f-e053-2a95a90adab92025-10-15WarningsExact identifier
application number: M020
Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defenseZINC OXIDECurology39a2a297-3af2-40d3-8b5d-f4eef2487fb22025-10-15WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral SunscreenZINC OXIDEColorescience00d8bf32-aecd-22da-e063-6294a90a75672025-10-15WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 SandZINC OXIDECosmetic Enterprises Ltd253c105b-215b-1e6e-e063-6294a90a11d72025-10-14WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 TanZINC OXIDECosmetic Enterprises Ltd265bbb1a-ba96-6598-e063-6394a90a94152025-10-14WarningsExact identifier
application number: M020
Resist Wrinkle Defense SPF 30 Paulas ChoiceZINC OXIDECosmetic Enterprises Ltdd658fdc7-9dac-47bf-8e83-1433a29a6cf62025-10-14WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd498b16c8-ba54-4a0a-8dbc-4b5cc368e2142025-10-14WarningsExact identifier
application number: M020
Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas ChoiceAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd3bf31626-5580-457b-8a59-cc37f4ab07672025-10-14WarningsExact 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