FDA.reportPublic FDA data

SPF30 Sunscreen

Product NDC
70412-238
11-digit product format
704120238
Labeler code
70412
Product ID
70412-238_0986ff76-6513-7704-e063-6294a90a9be2
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene, Ocitsalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Zhejiang Ayan Biotech Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 100; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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
SPF30 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal 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
44321dff-1a61-452f-8324-6de2a196db51Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-238-05SPF30 Sunscreen and Antibacterial Hand Sanitizer5 mL in 1 TUBESPRAY5 mL50 mg in 1mL6
70412-238-05SPF30 Sunscreen5 mL in 1 TUBESPRAY53
70412-238-08SPF30 Sunscreen8 mL in 1 BOTTLESPRAY83
70412-238-10SPF30 Sunscreen10 mL in 1 PACKAGESPRAY103
70412-238-20SPF30 Sunscreen20 mL in 1 BOTTLESPRAY203
70412-238-30SPF30 Sunscreen30 mL in 1 BOTTLESPRAY303
70412-238-60SPF30 Sunscreen60 mL in 1 BOTTLESPRAY603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-238SPF30 SUNSCREEN AND ANTIBACTERIAL HAND SANITIZER (ALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO., LTD.]6Current NDC, Legacy NDC20231108_b5e2458f-8e84-4e57-b6f7-e428a94c97a4.zip
70412-238SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATE) SPRAY [ZHEJIANG AYAN BIOTECH CO., LTD.]3Current NDC, Legacy NDC, 6 package rows20231108_44321dff-1a61-452f-8324-6de2a196db51.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 60 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bad1502-bc44-54ec-e063-6294a90ace8b2026-02-25WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs2e20c132-8a03-1d5d-e063-6394a90ad2c32026-02-25WarningsExact identifier
application number: M020
Rationale The Brilliance Tinted Serum SPF 50ZINC OXIDERATIONALE GROUP PTY LTD5c38506b-1533-435f-87a6-0452bae5b29f2026-02-24WarningsExact identifier
application number: M020
FULLY RICE CERAMIDE MOISTURE SUNSCREENZINC OXIDEAdapt Inc.d8bfe222-3184-4c98-9876-ef5ac81772b62026-02-24WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
application number: M020
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACKHOMOSALATE, OCTOCRYLENE, OCTISALATEPrinceville Productions, LLC, DBA Reunited Beauty4b961531-fbca-d1cf-e063-6294a90ab9a12026-02-24WarningsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.8f5e634c-765b-4ffe-bb12-753d64c90cf92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.e97bf30a-1465-4912-bd55-1e7dd993132b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.67efcd94-00af-477b-bd14-d1c7b95d305a2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen Mist SPF 100AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f642788c-3643-459a-b736-0c06d0cd32a92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.95ba2b33-f593-4e95-bd6e-5910d6aa51582026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3b85004a-8832-4eac-bd70-1e607ae7af4b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.7f0fc23b-2d70-4426-9d64-a6d2b643309f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.0ae9edd8-bf76-4bb2-ab78-c43c017ba4a52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f8960995-66b6-4197-8976-b318fe01488f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020364ethanol 62 % Topical SprayPSNb5e2458f-8e84-4e57-b6f7-e428a94c97a46
1020364ethanol 0.62 ML/ML Topical SpraySCDb5e2458f-8e84-4e57-b6f7-e428a94c97a46
1020364ethanol 62 % Topical SpraySYb5e2458f-8e84-4e57-b6f7-e428a94c97a46
1020364ethyl alcohol 62 % Topical SpraySYb5e2458f-8e84-4e57-b6f7-e428a94c97a46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70412-238-05704120238055 mL in 1 TUBE (70412-238-05) 5 ml2018-06-010000-00-00NoNoCurrent
70412-238-08704120238088 mL in 1 BOTTLE (70412-238-08) 8 ml2018-06-010000-00-00NoNoCurrent
70412-238-107041202381010 mL in 1 PACKAGE (70412-238-10) 10 ml2018-06-010000-00-00NoNoCurrent
70412-238-207041202382020 mL in 1 BOTTLE (70412-238-20) 20 ml2018-06-010000-00-00NoNoCurrent
70412-238-307041202383030 mL in 1 BOTTLE (70412-238-30) 30 ml2018-06-010000-00-00NoNoCurrent
70412-238-607041202386060 mL in 1 BOTTLE (70412-238-60) 60 ml2018-06-010000-00-00NoNoCurrent