FDA.reportPublic FDA data

Top Care 043.000/043AA Original Beauty Lotion SPF 15

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
37
Source
full-release
Hydrated at
2026-06-01 01:44:18

Label at a glance#

ProductBeauty Hydrating
Active ingredientHOMOSALATE, ZINC OXIDE
Label structure15 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 apply to all skin exposed to the sun reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 inc...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 5.0%

Zinc oxide 3.0%

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 if

OTC - STOP USE 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
  • apply to all skin exposed to the sun
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 the time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, tocopheryl acetate, Aloe barbadensis leaf extract, steareth-21, stearyl alcohol, caprylyl glycol, behenyl alcohol, phenoxyethanol, cetyl alcohol, fragrance, hydroxyacetophenone, disodium EDTA, steareth-2, oleth-3 phosphate

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Procter & Gamble, distributor of Olay ®Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 15 Normal.

May stain or damage some fabrics or surfaces.

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 © TOPCO VIJA0724

QUESTIONS? 1-888-423-0139

topcare@topco.com 

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

principal display panel - side panels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care ®beauty

ALL-DAY MOISTURIZER

Sunscreen Lotion

ALL-DAY MOISTURE

Formulated with Vitamin E and nourishing beauty moisture that absorbs quickly into skin and lasts all day to help your skin stay soft, smooth and beautiful.

UV PROTECTION

Broad-spetrum UVA and UVB protection with SPF 15 to help prevent premature skin damage

QUALITY GUARANTEED

This TopCare ®product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

Top Care ®beauty

ALL-DAY MOISTURIZER

Sunscreen Lotion

Light, non-greasy formula

Non-comedogenic (won't clog pores)

Phthalate free

Light, fast absorbing moisture lasts all day

Softens and smoothes for radiant-looking skin

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care ®beauty

ALL-DAY MOISTURIZER

Sunscreen Lotion

For Normal Skin

Compare to OLAY ®*

Broad spectrum SPF 15

Dermatologist tested

SPF 15

6 FL OZ (177 mL)

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-513-30Beauty Hydrating1 in 1 PACKAGELOTION137
36800-513-30Beauty Hydrating177 mL in 1 BOTTLE, PLASTICLOTION17737

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-51336800-513-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-7Z95S6G8201IACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
STEARETH-2153J3F32P58IACT
STEARYL ALCOHOL2KR89I4H1YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DOCOSANOL9G1OE216XYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL ALCOHOL936JST6JCNIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
EDETATE DISODIUM7FLD91C86KIACT
STEARETH-2V56DFE46J5IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-513-30
ndc (product): 36800-513
ndc11 (package): 36800051330
spl id: 4ab7966b-245e-3240-e063-6394a90a7338
spl set id: 6e88ccc8-8576-4573-8a5b-28e64008a349

Reported adverse events (FAERS/openFDA)#

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