FDA.reportPublic FDA data

Coppertone Wet and Clear Kids

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-11-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:57:10

Label at a glance#

ProductCoppertone Wet and Clear Kids SPF 50 Plus
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 S...

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 10%, Octisalate 4.5%, Octocrylene 9%, Oxybenzone 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

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

OTC - WHEN USING SECTION

When using this product

  • 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

SD Alcohol 40-B (49.5% V/V), C12-15 Alkyl Benzoate, Octyldodecyl Citrate Crosspolymer, Isohexadecane, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Tocopherol (Vitamin E), Ascorbyl Palmitate, C13-15 Alkane, Fragrance

Questions?

OTC - QUESTIONS SECTION

866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wet and Clear Kids SPF 50 cartonWet and Clear Kids SPF 50 carton

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
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N2
C13-15 AlkaneINACTIVE INGREDIENT114P5I43UJ2
IsododecaneINACTIVE INGREDIENTA8289P68Y22
IsohexadecaneINACTIVE INGREDIENT918X1OUF1E2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-735511523-7355-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOHEXADECANE918X1OUF1EIACT
ISODODECANEA8289P68Y2IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ASCORBYL PALMITATEQN83US2B0NIACT
C13-15 ALKANE114P5I43UJIACT
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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NTABLET / ORAL7.14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSYSTEM / TOPICAL0.04 mgExact identifier — unii candidate
6 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSUPPOSITORY / RECTAL16 mgExact identifier — unii candidate
6 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NCAPSULE / ORAL12 mgExact identifier — unii candidate
6 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.Alpha.-Tocopherol.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 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
9842b69b-0180-0664-e053-2995a90a97c2efd0f357-1247-4cb4-9c63-f040f62c46862019-11-26WarningsExact identifier
spl id: 9842b69b-0180-0664-e053-2995a90a97c2
spl set id: efd0f357-1247-4cb4-9c63-f040f62c4686

Reported adverse events (FAERS/openFDA)#

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