FDA.reportPublic FDA data

SPF30 SUNSCREEN LOTION

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:22

Label at a glance#

ProductSUNSCREEN 01
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
Label structure13 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 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...

Storage and handling

Protect this product from excessive heat and direct sun

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 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, Phenoxyethanol, Fragrance, Methylparaben, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Propylparaben, Disodium EDTA, BHT

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-01782953-017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-017-01SUNSCREEN0115 mL in 1 BOTTLE, PLASTICCREAM152
82953-017-02SUNSCREEN0130 mL in 1 BOTTLE, PLASTICCREAM302
82953-017-03SUNSCREEN0160 mL in 1 BOTTLE, PLASTICCREAM602
82953-017-04SUNSCREEN0175 mL in 1 BOTTLE, PLASTICCREAM752
82953-017-05SUNSCREEN0135 mL in 1 BOTTLE, PLASTICCREAM352
82953-017-06SUNSCREEN0150 mL in 1 BOTTLE, PLASTICCREAM502
82953-017-07SUNSCREEN01120 mL in 1 BOTTLE, PLASTICCREAM1202
82953-017-08SUNSCREEN01240 mL in 1 BOTTLE, PLASTICCREAM2402
82953-017-09SUNSCREEN01300 mL in 1 BOTTLE, PLASTICCREAM3002
82953-017-10SUNSCREEN0190 mL in 1 BOTTLE, PLASTICCREAM902
82953-017-11SUNSCREEN0120 mL in 1 BOTTLE, PLASTICCREAM202
82953-017-12SUNSCREEN0145 mL in 1 BOTTLE, PLASTICCREAM452
82953-017-13SUNSCREEN011.5 mL in 1 POUCHCREAM1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-017SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) CREAM [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, 13 package rows20240820_19a7dc68-6384-3783-e063-6394a90ac839.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82953-01782953-017-02, 82953-017-05, 82953-017-06, 82953-017-07, 82953-017-03, 82953-017-04, 82953-017-01, 82953-017-08, 82953-017-09, 82953-017-10, 82953-017-11, 82953-017-12, 82953-017-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
YELLOW WAX2ZA36H0S2VIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
OCTOCRYLENE5A68WGF6WMACTIB
CETETH-255KLY4IOG20IACT
METHYLPARABENA2I8C7HI9TIACT
HOMOSALATEV06SV4M95SACTIB
EDETATE DISODIUM7FLD91C86KIACT
LAURETH-7Z95S6G8201IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)RHA9LWJ494IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
FRAGRANCE 135765EM498GW35IACT

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
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a7dc68-6384-3783-e063-6394a90ac8392024-08-19WarningsExact identifier
ndc (package): 82953-017-07
ndc (package): 82953-017-08
ndc (package): 82953-017-04
ndc (package): 82953-017-05
ndc (package): 82953-017-01
ndc (package): 82953-017-03
ndc (package): 82953-017-09
ndc (package): 82953-017-13
ndc (package): 82953-017-10
ndc (package): 82953-017-12
ndc (package): 82953-017-02
ndc (package): 82953-017-06
ndc (package): 82953-017-11
ndc (product): 82953-017
ndc11 (package): 82953001707
ndc11 (package): 82953001709
ndc11 (package): 82953001703
ndc11 (package): 82953001702
ndc11 (package): 82953001701
ndc11 (package): 82953001710
ndc11 (package): 82953001704
ndc11 (package): 82953001705
ndc11 (package): 82953001708
ndc11 (package): 82953001711
ndc11 (package): 82953001713
ndc11 (package): 82953001706
ndc11 (package): 82953001712
spl id: 2005d677-73da-b231-e063-6394a90a5b9a
spl set id: 19a7dc68-6384-3783-e063-6394a90ac839

Reported adverse events (FAERS/openFDA)#

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