FDA.reportPublic FDA data

lip balm SPF15 ( Zinc oxide)

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-11 01:01:13

Label at a glance#

Productlip balm SPF15( Zinc oxide) 01
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. lf product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Triethoxycaprylylsilane, Petrolatum, Microcrystalline Wax, Mineral Oil, Beeswax, Tridecyl Trimellitate, Ozokerite, Cocos Nucifera(Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Polyisobutene, Butyrospermum Parkii (Shea)Butter, Tocopherol, Phenoxyethanol. Fragrance, BHT

other information

OTHER SAFETY INFORMATION

Protect from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panel 82953-074-0182953-074-01

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
82953-07482953-074-01, 82953-074-02, 82953-074-03, 82953-074-04, 82953-074-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
BEESWAX2ZA36H0S2VIACT
CERESINQ1LS2UJO3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FRAGRANCE 135765EM498GW35IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TOCOPHEROLR0ZB2556P8IACT
BHT1P9D0Z171KIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT

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
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
ndc (package): 82953-074-01
ndc (package): 82953-074-04
ndc (package): 82953-074-02
ndc (package): 82953-074-05
ndc (package): 82953-074-03
ndc (product): 82953-074
ndc11 (package): 82953007404
ndc11 (package): 82953007401
ndc11 (package): 82953007405
ndc11 (package): 82953007402
ndc11 (package): 82953007403
spl id: 5871ac2f-8fff-d995-e063-6394a90a3ef3
spl set id: 5871ab1d-cf07-d737-e063-6394a90a58fe

Reported adverse events (FAERS/openFDA)#

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