FDA.reportPublic FDA data

sunscreen SPF15 scent lip balm

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2026-09-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-11 03:03:10

Label at a glance#

ProductSPF15 lip balm 01
Active ingredientOCTOCRYLENE, OCTISALATE
Label structure12 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection

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 Sun protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includ...

Storage and handling

Protect from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 2%

Octisalate 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

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. 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
  • Sun protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

Other information

STORAGE AND HANDLING SECTION

Protect from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-00982953-009

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-00982953-009-01, 82953-009-02, 82953-009-03, 82953-009-04, 82953-009-05, 82953-009-06, 82953-009-07, 82953-009-08, 82953-009-09, 82953-009-10, 82953-009-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
ETHYLHEXYL PALMITATE2865993309IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CERESINQ1LS2UJO3AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-04full-release2026-06-01 00:40:27

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
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
ndc (package): 82953-009-04
ndc (package): 82953-009-08
ndc (package): 82953-009-02
ndc (package): 82953-009-09
ndc (package): 82953-009-11
ndc (package): 82953-009-10
ndc (package): 82953-009-01
ndc (package): 82953-009-05
ndc (package): 82953-009-07
ndc (package): 82953-009-03
ndc (package): 82953-009-06
ndc (product): 82953-009
ndc11 (package): 82953000902
ndc11 (package): 82953000910
ndc11 (package): 82953000909
ndc11 (package): 82953000908
ndc11 (package): 82953000911
ndc11 (package): 82953000904
ndc11 (package): 82953000901
ndc11 (package): 82953000907
ndc11 (package): 82953000905
ndc11 (package): 82953000903
ndc11 (package): 82953000906
spl id: 5b041426-bb48-2b14-e063-6294a90a8ced
spl set id: f8695305-b89d-c21c-e053-6394a90a0e84

Reported adverse events (FAERS/openFDA)#

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