FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate

Product NDC
72036-941
11-digit product format
720360941
Labeler code
72036
Product ID
72036-941_4a049ea1-820f-a733-e063-6394a90a9dfc
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
HARRIS TEETER
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-05
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 100; 50 mg/g; mg/g; mg/g
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
Avobenzone, Homosalate, Octisalate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g
OCTISALATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
0a3b4597-06fe-4689-9751-6577867d755eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72036-941-14Avobenzone, Homosalate, Octisalate156 g in 1 CANSPRAY1564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-941AVOBENZONE, HOMOSALATE, OCTISALATE SPRAY [HARRIS TEETER]2Current NDC, 1 package rows20240919_0a3b4597-06fe-4689-9751-6577867d755e.zip

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 244 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDEfmg Co.Ltdf114e45c-6c31-2382-e053-2995a90ac7542025-01-01WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDEfmg Co.Ltdd3078dd2-ae9c-d81a-e053-2a95a90a47bf2025-01-01WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDEfmg Co.Ltdd3078dd2-ae9e-d81a-e053-2a95a90a47bf2025-01-01WarningsExact identifier
application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdf8377d02-6c58-c240-e053-6294a90a44c02025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd67faeb3-0b73-5b6e-e053-2a95a90aac2b2025-01-01WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd02e63ed6-1f49-45c0-e063-6394a90a58bf2025-01-01WarningsExact identifier
application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd2fadd51-6bd8-ae70-e053-2995a90a62132025-01-01WarningsExact identifier
application number: M020
Jergens Natural Glow Face Moisturizer Medium to Deep Skin TonesAVOBENZONE,OCTISALATE, OCTOCRYLENEKao USA Inc.ff601f5c-b8ed-ee21-e053-6294a90aadba2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d309eebc-44f4-bce6-e053-2995a90a3bd22025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a3bcb-5113-0a85-e053-2995a90a39372025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.d30a9f96-f99b-4610-e053-2995a90a3f912025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a7ecc-ea54-d1b9-e053-2995a90a70172025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDELG H&H Co., Ltd.d30a87b9-90f9-35b2-e053-2995a90aea2c2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.d30ab7a5-d38c-ba62-e053-2995a90a57fd2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e82b4e-ce83-0ca2-e053-2a95a90a88de2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.0166d193-fc4d-51f7-e063-6294a90aaf322025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e831a1-c82f-3e1f-e053-2a95a90ae1f62025-01-01WarningsExact identifier
application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.d6e82b4e-ce84-0ca2-e053-2a95a90a88de2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co., Ltd.016798a8-4275-47d0-e063-6294a90a5aca2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDELG H&H Co., Ltd.f1166cb4-b471-7043-e053-2a95a90a7fa72025-01-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72036-941-1472036094114156 g in 1 CAN (72036-941-14) 156 g2023-09-05NoNoCurrent