FDA.reportPublic FDA data

TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN LOTION SPF 50

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 00:26:03

Label at a glance#

ProductTOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50
Active ingredientZINC OXIDE, OCTISALATE
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 casued 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...

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

Octisalate 5.0%, Zinc Oxide 14.5%

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 casued 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, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Propylene Glycol, Tridecyl Salicylate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Ethylhexyl Palmitate, Caprylyl Glycol, Phexoethanol, Hexylene Glycol, Sodium Chloride.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOP45625DTOP45625D

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-347-11TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-347TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 (OCTISALATE, ZINC OXIDE) LOTION [TOPCO ASSOCIATES LLC]2Current NDC, 1 package rows20241017_f71c9060-3daf-e1be-e053-6294a90a4f91.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-34736800-347-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM CHLORIDE451W47IQ8XIACT
CYCLOMETHICONE 4CZ227117JEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZOIC ACID8SKN0B0MIMIACT
SORBIC ACIDX045WJ989BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
ETHYLHEXYL PALMITATE2865993309IACT

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
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
ndc (package): 36800-347-11
ndc (product): 36800-347
ndc11 (package): 36800034711
spl id: 24882f00-521b-2de9-e063-6394a90a1bf9
spl set id: f71c9060-3daf-e1be-e053-6294a90a4f91