FDA.reportPublic FDA data

Sunscreen, anti-mosquito LOTION

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:27

Label at a glance#

ProductSun ,Bug Handsfree 01
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
Label structure12 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by then sun.

Dosage and administration

apply liberally 15minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediate after towel drying at least every 2 hours Sun Protection Measures Spending time increases your risk of skin cancer and early skin aging. To decreases 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, especial...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by then sun.

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 prduct is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediate after towel drying
  • at least every 2 hours
  • Sun Protection Measures

Spending time increases your risk of skin cancer and early skin aging. To decreases 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.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months:Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Beeswax, Citronella oil, Lemongrass oil, peppermint oil, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-01082953-010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-010-01Sun ,Bug Handsfree0110 mL in 1 BOTTLE, PLASTICCREAM102
82953-010-02Sun ,Bug Handsfree0115 mL in 1 BOTTLE, PLASTICCREAM152
82953-010-03Sun ,Bug Handsfree0130 mL in 1 BOTTLE, PLASTICCREAM302
82953-010-04Sun ,Bug Handsfree0160 mL in 1 BOTTLE, PLASTICCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-010SUN ,BUG HANDSFREE 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) CREAM [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, 4 package rows20241206_f8f29aec-935f-e828-e053-6394a90a570a.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-01082953-010-01, 82953-010-02, 82953-010-03, 82953-010-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
CITRONELLA OILQYO8Q067D0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EAST INDIAN LEMONGRASS OILUP0M8M3VZWIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
YELLOW WAX2ZA36H0S2VIACT
OCTOCRYLENE5A68WGF6WMACTIB
CETETH-255KLY4IOG20IACT
METHYLPARABENA2I8C7HI9TIACT
HOMOSALATEV06SV4M95SACTIB
GLYCERYL STEARATE SEFCZ5MH785IIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

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
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
ndc (package): 82953-010-04
ndc (package): 82953-010-01
ndc (package): 82953-010-02
ndc (package): 82953-010-03
ndc (product): 82953-010
ndc11 (package): 82953001002
ndc11 (package): 82953001004
ndc11 (package): 82953001001
ndc11 (package): 82953001003
spl id: 286c7e0d-8bc2-2611-e063-6294a90af754
spl set id: f8f29aec-935f-e828-e053-6394a90a570a

Reported adverse events (FAERS/openFDA)#

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