FDA.reportPublic FDA data

SPF15

Product NDC
70412-316
11-digit product format
704120316
Labeler code
70412
Product ID
70412-316_20984ed2-b2c4-56bb-e063-6394a90a85c2
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
LIPSTICK
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
20; 80; 55; 20 mg/g; mg/g; mg/g; mg/g
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
SPF15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE20 mg/g
HOMOSALATE80 mg/g
OCTOCRYLENE55 mg/g
OCTISALATE20 mg/g

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
2bb9798f-36a0-4d03-a316-8b746a9283d8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-316-07SPF152 g in 1 TUBELIPSTICK25
70412-316-09SPF159 g in 1 BOTTLELIPSTICK95
70412-316-15SPF154.5 g in 1 TUBELIPSTICK4.55
70412-316-20SPF155.67 g in 1 TUBELIPSTICK5.675
70412-316-07SPF30 Sunscreen and SPF152 g in 1 TUBELIPSTICK2 g20 mg in 1g2
70412-316-15SPF 15 Lip and SPF 30 Sunscreen4.5 g in 1 TUBELIPSTICK4.5 g80 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-316SPF15 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LIPSTICK [ZHEJIANG AYAN BIOTECH CO.,LTD.]5Current NDC, Legacy NDC, 4 package rows20240828_2bb9798f-36a0-4d03-a316-8b746a9283d8.zip
70412-316SPF30 SUNSCREEN AND SPF15 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]2Current NDC, Legacy NDC20231108_6c40259b-565a-46d0-90d0-ccc186764552.zip
70412-316SPF 15 LIP AND SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]1Current NDC, Legacy NDC20180601_52f03bbe-76a3-43fb-b64f-e3e81f9e0558.zip
70412-316SPF 15 LIP AND SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]1Current NDC, Legacy NDC20231129_0b385246-dc77-6874-e063-6394a90a5959.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 71 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.ea630f2c-49a7-4900-a0ac-b0e1c554aff92026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.cc9c9b69-a0ea-44ac-a590-2cd241ce31622026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e38a10a8-73ac-4fc5-bbde-537ccb845e6f2026-01-22WarningsExact identifier
application number: M020
Designer Lip Smoothie SPF 15 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMAustralian Gold6fd1bd4f-ef94-42b5-a26c-2a02718c113f2026-01-22WarningsExact identifier
application number: M020
Australian Gold SPF 15 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYAustralian Gold92966c2d-b61a-4f8b-a5c1-8dfb6352c82f2026-01-22WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50gAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATEDONGDONGGURIMOO CO.,LTD.4907eb9c-3978-27ed-e063-6394a90a9f662026-01-22WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.be9f7608-cfaa-4b16-83dd-0580047af56c2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6b27df44-c441-4ae8-a1b0-a9cf2fff6f212026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3c295f6b-6202-a2e1-e063-6394a90a9a602026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.b2eee48f-b644-403c-a57e-04a1491bc3862026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ebcc2c6c-a039-48d5-8c1c-5b347254c4c22026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6967f8bc-3092-44a9-926a-6c11676425e52026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.37d4d8c1-e76b-48a3-9a13-f0543af1b28f2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact identifier
application number: M020
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY48e8b7f5-6977-bfae-e063-6394a90a888b2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Gold32725ca7-ec21-4643-bdc6-278fd647b95d2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Golde6877f7a-3aaa-4096-bcb5-eae0aa2532e52026-01-21WarningsExact identifier
application number: M020
MINICELL UV SHIELD SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECELINA CO., LTD.48eff8fa-deec-a434-e063-6294a90aa8612026-01-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70412-316-07704120316072 g in 1 TUBE (70412-316-07) 2 g2018-12-010000-00-00NoNoCurrent
70412-316-09704120316099 g in 1 BOTTLE (70412-316-09) 9 g2024-10-20NoNoCurrent
70412-316-15704120316154.5 g in 1 TUBE (70412-316-15) 4.5 g2018-06-010000-00-00NoNoCurrent
70412-316-20704120316205.67 g in 1 TUBE (70412-316-20) 5.67 g2018-06-010000-00-00NoNoCurrent