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
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
SPF30 Sunscreen
Listing expiration
2027-12-31

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 197 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI038ec45a-0d56-4cd9-8060-767b382c12372025-08-06WarningsExact identifier
application number: M020
GR CC Broad Spectrum SPF 30OCTINOXATE, OXYBENZONEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI751d5194-f5ea-401b-9439-7770510a588c2025-08-06WarningsExact identifier
application number: M020
GR NUDE LOOK SPF 25AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96dae912-8fa5-4d0e-b873-e1dbb7398db02025-08-06WarningsExact identifier
application number: M020
GR BB SPF 25OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI3b22579b-21ce-4b96-bd24-774ce35bf6f72025-08-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Invisible Gel Face Sunscreen SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3b9a4bd9-cbe1-60c5-e063-6394a90a58922025-08-05WarningsExact identifier
application number: M020
Neutrogena Hydro Boost City Shield water Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC77e4bbcc-0a51-4e9c-9328-46bcbf4f81292025-08-05WarningsExact identifier
application number: M020
Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCdecb4842-c880-0668-e053-2995a90aad7e2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 08W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L498bf941-67f2-41d5-a039-9f827b68297e2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 10N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L54e390bd-b84a-4c43-986e-74923e34689d2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 09C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L897024cd-576e-4a8e-8daa-92dc3bb4b3a52025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 11W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L303967d1-9df8-4a8e-a264-6b0d8fdbf2a82025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 12N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L26062cd7-3817-46c7-b65f-92cd57eca5dd2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
application number: M020
JORDAN FAT KIDS Tallow Sunscreen SPF 30MENTHOL, METHYL SALICYLATEJORDAN FAT KIDS LLC72ac88cf-9f20-44ea-b3a2-12c922eec2b32025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact 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