FDA.reportPublic FDA data

SPF30 Sunscreen

Product NDC
70412-231
11-digit product format
704120231
Labeler code
70412
Product ID
70412-231_098708e4-06f3-7b7e-e063-6294a90ad447
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene, Ocitsalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Zhejiang Ayan Biotech Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-01
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
cac6f5e5-91c2-4978-bffd-5ca2a7590637Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-231-15SPF30 Sunscreen15 mL in 1 BOTTLELOTION155
70412-231-20SPF30 Sunscreen20 mL in 1 BOTTLELOTION205
70412-231-30SPF30 Sunscreen30 mL in 1 BOTTLELOTION305
70412-231-35SPF30 Sunscreen35 mL in 1 BOTTLELOTION355
70412-231-45SPF30 Sunscreen45 mL in 1 BOTTLELOTION455
70412-231-53SPF30 Sunscreen53 mL in 1 BOTTLELOTION535
70412-231-60SPF30 Sunscreen60 mL in 1 BOTTLELOTION605
70412-231-30SPF30 Sunscreen and SPF1530 mL in 1 BOTTLELOTION30 mL100 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-231SPF30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATE) LOTION [ZHEJIANG AYAN BIOTECH CO., LTD.]5Current NDC, Legacy NDC, 7 package rows20231129_cac6f5e5-91c2-4978-bffd-5ca2a7590637.zip
70412-231SPF30 SUNSCREEN AND SPF15 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]2Current NDC, Legacy NDC20231108_6c40259b-565a-46d0-90d0-ccc186764552.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 130 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359684cf-ca11-f9af-e063-6394a90ac4c12025-12-12Exact identifier
application number: M020
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
application number: M020
JAYSUING Rice Probiotics SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.45cdc741-9ce0-fd6c-e063-6294a90adc0b2025-12-12WarningsExact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
application number: M020
Signature Tint SPF 40ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348f1bd3-1245-2d9a-e063-6394a90a47872025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a54441-c741-0c46-e063-6294a90a9be82025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37620171-140d-e096-e063-6294a90af93b2025-12-11Exact identifier
application number: M020
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
application number: M020
D FEND DAILYZINC OXIDECLEAN BEAUTY BY ANAK LLC3762dc16-055e-43fd-e063-6394a90ad3c82025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a66140-0d36-005a-e063-6394a90a2a0b2025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37634726-fb70-f209-e063-6294a90a5d3b2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
application number: M020
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374e1c8e-5c5c-9198-e063-6294a90a3b882025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70412-231-157041202311515 mL in 1 BOTTLE (70412-231-15) 15 ml2018-07-010000-00-00NoNoCurrent
70412-231-207041202312020 mL in 1 BOTTLE (70412-231-20) 20 ml2018-07-010000-00-00NoNoCurrent
70412-231-307041202313030 mL in 1 BOTTLE (70412-231-30) 30 ml2018-07-010000-00-00NoNoCurrent
70412-231-357041202313535 mL in 1 BOTTLE (70412-231-35) 35 ml2018-07-010000-00-00NoNoCurrent
70412-231-457041202314545 mL in 1 BOTTLE (70412-231-45) 45 ml2018-07-010000-00-00NoNoCurrent
70412-231-537041202315353 mL in 1 BOTTLE (70412-231-53) 53 ml2018-07-010000-00-00NoNoCurrent
70412-231-607041202316060 mL in 1 BOTTLE (70412-231-60) 60 ml2018-07-010000-00-00NoNoCurrent