FDA.reportPublic FDA data

Coppertone KIDS

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-07-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:04:01

Label at a glance#

ProductCoppertone KIDS SPF 55
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 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 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...

Storage and handling

protect this product from excessive heat and direct sun may stain or damage some fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is 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
  • 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Lauryl Laurate, Ozokerite, Cetearyl Behenate, Polybutene, Cetyl Alcohol, Styrene/Acrylates Copolymer, Myristyl Myristate, Tocopherol (Vitamin E), Theobroma Cacao (Cocoa) Seed Butter, Phenoxyethanol, Retinyl Palmitate (Vitamin A Palmitate),Tetrahexyldecyl Ascorbate

Questions?

OTC - QUESTIONS SECTION

866-288-3330

PRINCIPAL DISPLAY PANEL - 17g Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Look

Coppertone ®
SUNSCREEN STICK

kids 55 ®

#1 PEDIATRICIAN
RECOMMENDED
BRAND

Water Resistant
(80 minutes)

55

NET WT 0.6 OZ (17g)

front labelfront label

back labelback label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX2
HomosalateACTIVE INGREDIENTV06SV4M95S2
OctisalateACTIVE INGREDIENT4X49Y0596W2
OctocryleneACTIVE INGREDIENT5A68WGF6WM2
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y2
AvobenzoneACTIVE MOIETYG63QQF2NOX2
HomosalateACTIVE MOIETYV06SV4M95S2
OctisalateACTIVE MOIETY4X49Y0596W2
OctocryleneACTIVE MOIETY5A68WGF6WM2
OxybenzoneACTIVE MOIETY95OOS7VE0Y2
alpha-tocopherolINACTIVE INGREDIENTH4N855PNZ12
cetearyl behenateINACTIVE INGREDIENT7ARI9LTH0U2
cetyl alcoholINACTIVE INGREDIENT936JST6JCN2
cocoa butterINACTIVE INGREDIENT512OYT1CRR2
lauryl laurateINACTIVE INGREDIENTGPW77G09372
myristyl myristateINACTIVE INGREDIENT4042ZC00DY2
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZ2
vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVC2
yellow waxINACTIVE INGREDIENT2ZA36H0S2V2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-730611523-7306-1, 11523-7306-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
LAURYL LAURATEGPW77G0937IACT
CETEARYL BEHENATE7ARI9LTH0UIACT
CETYL ALCOHOL936JST6JCNIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
COCOA BUTTER512OYT1CRRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL201 mgExact identifier — unii candidate
20 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL84 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL75 mgExact identifier — unii candidate
6 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL357 mgExact identifier — unii candidate
9 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
cocoa butterCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
yellow waxYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
alpha-tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
8ed76b45-b6c0-4dc1-e053-2a95a90a43a962975ab6-0ec5-4595-bd92-d25c1d694cbe2019-07-29WarningsExact identifier
spl id: 8ed76b45-b6c0-4dc1-e053-2a95a90a43a9
spl set id: 62975ab6-0ec5-4595-bd92-d25c1d694cbe

Reported adverse events (FAERS/openFDA)#

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