FDA.reportPublic FDA data

TOPCARE EVERYDAY SPORT SPF 70 SUN LOTION

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:25:49

Label at a glance#

ProductTOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE
Label structure12 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection mesaures (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 of age: 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 pr...

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 3.0%, Octocrylene 7.0%, Oxybenzone 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection mesaures (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 if

OTC - ASK DOCTOR SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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 of age: 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, propylene glycol, styrene/acrylates copolymer, silica, aluminum starch octenylsuccinate, behenyl alcohol, butylated PVP, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, diethylhexyl syringylidenemalonate, caprylic/capric triglyceride, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, disodium EDTA, butylene glycol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE EVERYDAY SPORT SPF 70 SUN LOTION

8 FL OZ. (237mL)

NDC 36800-940-11

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-940-11TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN237 mL in 1 BOTTLELOTION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-940TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 1 package rows20241017_a5b06600-f2b0-6d9b-e053-2995a90a59f0.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-94036800-940-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
PODOPHYLLUM PELTATUM ROOT2S713A4VP3IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
BENZYL ALCOHOLLKG8494WBHIACT
STEARIC ACID4ELV7Z65APIACT
LAURYL ALCOHOL178A96NLP2IACT
EDETATE DISODIUM7FLD91C86KIACT
CHAMOMILEFGL3685T2XIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
WATER059QF0KO0RIACT
DOCOSANOL9G1OE216XYIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CHLORPHENESINI670DAL4SZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PALMITIC ACID2V16EO95H1IACT
MYRISTYL ALCOHOLV42034O9PUIACT
CETYL ALCOHOL936JST6JCNIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML · Source PDF

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 SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
ndc (package): 36800-940-11
ndc (product): 36800-940
ndc11 (package): 36800094011
spl id: 24882a07-8b8c-16d8-e063-6394a90aec7a
spl set id: a5b06600-f2b0-6d9b-e053-2995a90a59f0

Reported adverse events (FAERS/openFDA)#

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