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
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
SPF15
Listing expiration
2027-12-31

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 102 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAYAVOBENZONE, OCTINOXATE, OCTISALATEKOS America, Inc.81352963-36ec-4099-af51-3498d89f30772025-12-23WarningsExact identifier
application number: M020
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen dropsZINC OXIDE, OCTINOXATELongway Technology(Guangzhou)Co.,Ltd.451b4d37-99e2-8e4f-e063-6294a90a51bb2025-12-23WarningsExact identifier
application number: M020
Reclaim Revolutionary Anti-Aging Day SPF15OCTINOXATE, OCTISALATE, AND OXYBENZONEGuthy-Renker LLC4b735c91-f650-4531-8744-c211d57a3e282025-12-23WarningsExact identifier
application number: M020
SCINIC ENJOY SUPER MILD SUN ESSENCE EXAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEELEVEN STREET35272744-8253-046c-e063-6394a90aabc22025-12-22WarningsExact identifier
application number: M020
TINTED FACIAL SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1259035e-9196-97de-e063-6394a90a9dec2025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP BALMETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.0f8e08bf-4b14-bdad-e063-6394a90a34e12025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.1c32b019-a038-eb61-e063-6394a90a45f22025-12-22WarningsExact identifier
application number: M020
SPF 50 MINERAL SUNSCREEN LIPZINC OXIDE , TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1c6f0964-9bee-1c06-e063-6294a90ac2a42025-12-22WarningsExact identifier
application number: M020
Absolut Skin SPF 50 Moisturizing SunscreenETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.3264543c-e8f5-da9a-e063-6394a90ac8c62025-12-22WarningsExact identifier
application number: M020
Firmarine Moisturizer SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATEErno Laszlo, Inc.073f8b95-6f46-4341-817f-22f5b4f325422025-12-22WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.468c90d7-3b9e-1641-e063-6394a90a928c2025-12-22WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3e65ec1a-0ed9-433d-8da9-a6cb618299112025-12-22WarningsExact identifier
application number: M020
Sun Shades Sunscreen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMelaleuca Inc.1f982f03-9542-29f9-e063-6294a90a959c2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.ca99b8c4-6778-43dc-bdd5-ca4a470860a02025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f810843b-5a4d-6cbc-e053-6294a90ac9e32025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.7a5644b9-4368-4e9a-aa22-b3307acf43cc2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30ZINC OXIDESOLARA SUNCARE, INC.cbf9c715-2d45-4c1b-b58f-42795722821c2025-12-22WarningsExact identifier
application number: M020
SPF 50 Baby Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc4690d89b-ae61-2ed5-e063-6294a90a743f2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50ZINC OXIDESOLARA SUNCARE, INC.f5242c7d-09e1-4141-8de1-a89bd7981ca62025-12-22WarningsExact 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