FDA.reportPublic FDA data

Coppertone Kids Sunscreen

Manufacturer
Bayer HealthCare LLC
Effective date
2019-08-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:13:11

Label at a glance#

ProductCoppertone Kids Sunscreen SPF 70
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 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 do not spray directly on face. Spray into hands and apply to face use in well-ventilated areas 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 Sp...

Storage and handling

may stain or damage some fabrics or surfaces avoid long term storage above 40°C (104°F) protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Flammable

SPL UNCLASSIFIED SECTION

Do not use near heat, flame, or while smoking.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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
  • do not spray directly on face. Spray into hands and apply to face
  • use in well-ventilated areas
  • 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

  • may stain or damage some fabrics or surfaces
  • avoid long term storage above 40°C (104°F)
  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat. (63.5% V/V), Acrylates/Octylacrylamide Copolymer, Glycerin, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Fragrance, Retinyl Palmitate (Vitamin A Palmitate), Caprylic/Capric Triglyceride

Questions?

OTC - QUESTIONS SECTION

866-288-3330

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coppertone ®

SUNSCREEN CONTINUOUS SPRAY

kids

Broad

Spectrum

SPF

70

#1 PEDIATRICIAN

RECOMMENDED BRAND

Won't Run Into

Eyes And Sting

Water Resistant

(80 minutes)

70

6 FL OZ (177 mL)

Six ounce carton labelSix ounce carton label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX3
HomosalateACTIVE INGREDIENTV06SV4M95S3
OctisalateACTIVE INGREDIENT4X49Y0596W3
OctocryleneACTIVE INGREDIENT5A68WGF6WM3
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y3
AvobenzoneACTIVE MOIETYG63QQF2NOX3
HomosalateACTIVE MOIETYV06SV4M95S3
OctisalateACTIVE MOIETY4X49Y0596W3
OctocryleneACTIVE MOIETY5A68WGF6WM3
OxybenzoneACTIVE MOIETY95OOS7VE0Y3
.Alpha.-TocopherolINACTIVE INGREDIENTH4N855PNZ13
alcoholINACTIVE INGREDIENT3K9958V90M3
glycerinINACTIVE INGREDIENTPDC6A3C0OX3
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U3
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-731611523-7316-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
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 3 · 162 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 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
8f60d077-6f96-9ded-e053-2a95a90ac9ff5ef3d38d-837d-4cd5-b04c-3fc27cdc1ecb2019-08-05WarningsExact identifier
spl id: 8f60d077-6f96-9ded-e053-2a95a90ac9ff
spl set id: 5ef3d38d-837d-4cd5-b04c-3fc27cdc1ecb

Reported adverse events (FAERS/openFDA)#

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