Topcare Everyday Ultimate Sheer Sun Lotion Broad Spectrum SPF 55

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:25:54

Label at a glance#

ProductTopcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55
Active ingredientOCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONE
Label structure12 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see ​Directions ​), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • 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 ...

Storage and handling

• protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 7.0%,

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun

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

reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, tridecyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, behenyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, dimethicone, tocopheryl acetate, ethylhexylglycerin, caprylyl methicone, ethylhexyl stearate, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, fragrance

Other information

STORAGE AND HANDLING SECTION

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOP45624A1TOP45624A1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-167-09Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 5589 mL in 1 TUBELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-167TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 55 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241017_c6268778-8dcc-24b6-e053-2995a90acf03.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-16736800-167-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc6268778-8dcc-24b6-e053-2995a90acf032024-10-15WarningsExact identifier
ndc (package): 36800-167-09
ndc (product): 36800-167
ndc11 (package): 36800016709
spl id: 2487df86-039b-4d33-e063-6394a90acb50
spl set id: c6268778-8dcc-24b6-e053-2995a90acf03

Reported adverse events (FAERS/openFDA)#

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