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 34 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord12905b6-97aa-429a-8800-23856fe31f062026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43599d17-81f4-4c6e-b6bd-d1e700b668ee2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior116f09db-f859-40c5-8857-33503903ee762026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior480e5bf9-8e24-4335-a434-93255ceb640e2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7057feab-20fe-4547-8223-0816904bcfd62026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior672a804d-ba8e-4c03-91fc-3edc0b12c6272026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb656394d-a410-4f8c-a632-815a349fb17e2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4d47292f-35f2-4e9f-a9d8-2df57cbe92cf2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior96258152-5255-4f04-9a35-c5a76b9c05202026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5df158da-3280-4ce6-a04c-3709993434002026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbe60feb0-8c16-4ef6-a36f-423ed18e098c2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d7678b4-b082-4911-80a2-c019eb5294142026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior00c9da7c-d4c7-49da-afa9-1fde93a815402026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior201acd8e-23c6-43fd-81dc-a814c3d8160b2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb24806b1-d9da-4373-b072-6d9a262ea3652026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc981ae5e-e7e8-484b-b682-fb96d501e03b2026-05-06WarningsExact identifier
application number: M020
Poth Clear Gel Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPoth LLC1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17a2026-05-06WarningsExact identifier
application number: M020
FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPFFORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPFHorizons Ventures LLC5127ac89-3dff-5966-e063-6394a90a11db2026-05-06WarningsExact identifier
application number: M020
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDEHave & Be Co., Ltd.4a7e868d-6310-6ee4-e063-6394a90aebce2026-05-06WarningsExact identifier
application number: M020
Vivaiodays Sunscreen with TurmericZINC OXIDE5SENCO INC DBA VIVAIODAYS5129e680-f485-9c66-e063-6394a90a0e7e2026-05-06WarningsExact 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