FDA.reportPublic FDA data

Lip Balm SPF15

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2020-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:08:56

Label at a glance#

ProductLip Balm SPF15
Active ingredientOCTINOXATE, OXYBENZONE
Label structure7 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

Ethylhexyl Methoxycinnamate 7.5%

Benzophenone-3 3%

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

Beeswax, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglycerides, Copernicia Cerifera (Carnauba) Wax, Ethylhexyl Palmitate, Flavor, Microcrystalline Wax, Ozokerite Wax, Petrolatum, Pentaerythrityl Tetraisostearate, Polybutene, Punica Granatum Extract, Vitis Vinifera
(Grape) Seed Extract, Tocopheryl Acetate, Triticum Vulgare (Wheat) Germ Oil.

Other Information

SPL UNCLASSIFIED SECTION

• Protect from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label23Label23

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70412-315-152020-02-28C16284748780-19d75b9d0-53c8-f424-e053-dadaa90a57ceLip Balm SPF15
70412-315-152020-01-31C16284748780-19d75b9d0-53c8-f424-e053-dadaa90a57ceLip Balm SPF15

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-31570412-315-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARNAUBA WAXR12CBM0EIZIACT
ETHYLHEXYL PALMITATE2865993309IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHEAT GERM OIL14C97E680PIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b349072d-c814-8e85-e053-2a95a90ad10dcbc839db-8759-45fe-ad40-5965272273aa2020-11-04WarningsExact identifier
spl id: b349072d-c814-8e85-e053-2a95a90ad10d
spl set id: cbc839db-8759-45fe-ad40-5965272273aa

Reported adverse events (FAERS/openFDA)#

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