FDA.reportPublic FDA data

Top Care D47.001/D47AA Sunscreen Lotion for Babies SPF 50

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-22 01:01:40

Label at a glance#

ProductAvobenzone, Homosalate, Octisalate
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure14 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: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 12%

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), 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:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol

Disclaimer

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO VIJA0326

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

QUALITY GUARANTEED

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

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®

everyday

baby sunscreen lotion

SPF 50

BROAD SPECTRUM SPF 50

SUNSCREEN UVA/UVB

HYPOALLERGENIC*

*Individual skin sensitivities may vary.

WITH ALOE & VITAMIN E

Formulated without Phthalates, PABA, Dyes, Octinoxate, Octocrylene or Oxybenzone

water resistant (80 minutes)

8 FL OZ (236 mL)

mm01mm01

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-94776162-947-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
POLYESTER-70841698D2FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CHLORPHENESINI670DAL4SZIACT
BENZYL ALCOHOLLKG8494WBHIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
DOCOSANOL9G1OE216XYIACT
TOCOPHEROLR0ZB2556P8IACT
YELLOW WAX2ZA36H0S2VIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
GERANIOLL837108USYIACT

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
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
ndc (package): 76162-947-34
ndc (product): 76162-947
ndc11 (package): 76162094734
spl id: 597b78df-83cc-1b21-e063-6294a90a56a8
spl set id: 597b78df-83cb-1b21-e063-6294a90a56a8

Reported adverse events (FAERS/openFDA)#

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