FDA.reportPublic FDA data

Homosalate, Octisalate, Zinc oxide

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:44:13

Label at a glance#

ProductHomosalate, Octisalate, Zinc oxide
Active ingredientHOMOSALATE, ZINC OXIDE, OCTISALATE
Label structure17 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 {and evenly} 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 meas...

Label contents#

Full prescribing information#

Claims

SPL UNCLASSIFIED SECTION

Top Care ® beauty

Morning Facial Moisturizing Lotion

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octisalate 5%

Zinc Oxide 6.3%

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 {and evenly} 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 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, cetearyl alcohol, niacinamide, behentrimonium methosulfate, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, triethoxycaprylylsilane, chlorphenesin, sodium lauroyl lactylate, cholesterol, aluminum starch octenylsuccinate, disodium EDTA, sodium hydroxide, benzyl alcohol, hydroxyethylcellulose, sodium hyaluronate, phytosphingosine, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Disclaimers

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces.

*This product is not manufactured or distributed by L’Oreal USA S/D, Inc., distributor of CeraVe ® AM Facial Moisturizing Lotion with Sunscreen Broad Spectrum SPF 30.

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ITASCA, IL 60143 ©TOPCO

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

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

QUALITY GUARANTEED

Top Panel and Side Panel Claims

SPL UNCLASSIFIED SECTION

Top Care ® beauty

Compare to CeraVe ® AM Facial Moisturizing Lotion*

Morning Facial Moisturizing Lotion

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to CeraVe ® AM Facial Moisturizing Lotion*

Top Care ® beauty

Morning Facial Moisturizing Lotion

Dermatologist Tested

Contains Ceramides, Niacinamide & Hyaluronic Acid

BROAD SPECTRUM 30 SPF

3 FL OZ (89 mL)

mm01mm01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-957-21Homosalate, Octisalate, Zinc oxide89 mL in 1 BOTTLE, PLASTICLOTION892
76162-957-21Homosalate, Octisalate, Zinc oxide1 in 1 CARTONLOTION12

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
76162-95776162-957-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CERAMIDE 15THT33P7X7IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CHLORPHENESINI670DAL4SZIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE APF1X8L2B00JIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EDETATE DISODIUM7FLD91C86KIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
HOMOSALATEV06SV4M95SACTIB
WATER059QF0KO0RIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
CERAMIDE NP4370DF050BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
NIACINAMIDE25X51I8RD4IACT
BENZYL ALCOHOLLKG8494WBHIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-22monthly-update2026-06-03 17:53:08

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
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 76162-957-21
ndc (product): 76162-957
ndc11 (package): 76162095721
spl id: 4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0
spl set id: 48fb9a3c-c058-ce71-e063-6294a90aaf1e

Reported adverse events (FAERS/openFDA)#

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