FDA.reportPublic FDA data

SPF 15 Lip and SPF 30 Sunscreen

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2018-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:19

Label at a glance#

ProductSPF 15 Lip and SPF 30 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure15 sections

Indications and uses

• Helps prevent sunburn.

Dosage and administration

• Apply liberally 15 minutes before sun exposure. • Use 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

Homosalate 2%
Avobenzone 8%
Octocrylene 5.5%
Octisalate 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 rash 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure. • Use 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, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl 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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 2%
Avobenzone 8%
Octocrylene 5.5%
Octisalate 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 rash 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure. • Use 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, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Hydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Tridecyl Trimellitate, Ozokerite, Synthetic Wax, Dextrin Palmitate, BHT, Tocopheryl Acetate, Fragrance.

Other Information

SPL UNCLASSIFIED SECTION

• Protect from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Call AP Specialties

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70412-816-102024-01-30C16284748780-11030e365-1d53-111a-e063-dadaa90a10e2SPF 15 Lip Balm and SPF 30Sunscreen Stick

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-211SPF 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 NDC20180601_52f03bbe-76a3-43fb-b64f-e3e81f9e0558.zip
70412-816SPF 15 LIP AND SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) KIT [ZHEJIANG AYAN BIOTECH CO.,LTD.]1Legacy NDC20180601_52f03bbe-76a3-43fb-b64f-e3e81f9e0558.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-81670412-816-10
70412-31670412-316-15
70412-21170412-211-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
YELLOW WAX2ZA36H0S2VIACT
CERESINQ1LS2UJO3AIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYL PALMITATE2865993309IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
SHEA BUTTERK49155WL9YIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
YELLOW WAX2ZA36H0S2VIACT
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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6759b9f7-296a-4c06-9198-b4e824e0bdc92026-06-25WarningsExact identifier
ndc (package): 70412-211-15
ndc (product): 70412-211
ndc11 (package): 70412021115
SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.2bb9798f-36a0-4d03-a316-8b746a9283d82024-08-26WarningsExact identifier
ndc (package): 70412-316-15
ndc (product): 70412-316
ndc11 (package): 70412031615
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
6cf6a310-472d-1fe6-e053-2991aa0a60fd52f03bbe-76a3-43fb-b64f-e3e81f9e05582018-05-24WarningsExact identifier
spl id: 6cf6a310-472d-1fe6-e053-2991aa0a60fd
spl set id: 52f03bbe-76a3-43fb-b64f-e3e81f9e0558

Reported adverse events (FAERS/openFDA)#

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