FDA.reportPublic FDA data

SPF15

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2024-08-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:17:51

Label at a glance#

ProductSPF15
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Usa a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if reash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Usa a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Call AP Specialties 

BATCH NO:

Distributed by:

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 70412-316-09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-31670412-316-15, 70412-316-20, 70412-316-07, 70412-316-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
SHEA BUTTERK49155WL9YIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.2bb9798f-36a0-4d03-a316-8b746a9283d82024-08-26WarningsExact identifier
ndc (package): 70412-316-20
ndc (package): 70412-316-15
ndc (package): 70412-316-09
ndc (package): 70412-316-07
ndc (product): 70412-316
ndc11 (package): 70412031615
ndc11 (package): 70412031609
ndc11 (package): 70412031620
ndc11 (package): 70412031607
spl id: 20984ed2-b2c4-56bb-e063-6394a90a85c2
spl set id: 2bb9798f-36a0-4d03-a316-8b746a9283d8
SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.0b385246-dc77-6874-e063-6394a90a59592023-11-20WarningsExact identifier
ndc (package): 70412-316-15
ndc11 (package): 70412031615
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
ndc (package): 70412-316-07
ndc11 (package): 70412031607

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.