FDA.reportPublic FDA data

Coppertone Water Babies Pure And Simple Whipped

Manufacturer
Bayer Healthcare LLC.
Effective date
2019-08-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:04:40

Label at a glance#

ProductCoppertone Water Babies Pure And Simple Whipped SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Indications and uses

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

Directions apply liberally 15 minutes before sun exposure do not dispense or apply directly on face. Dispense 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...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,

Octocrylene 4%, Oxybenzone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

OTC - DO NOT USE SECTION

Warnings

For external use only

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling

the contents can be harmful or fatal.

  • do not puncture or incinerate. Contents under pressure. Do not store at

temperatures above 120°F.

Stop use and as a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children

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

Directions

apply liberally 15 minutes before sun exposure

do not dispense or apply directly on face. Dispense 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 and higher and other sun protection measures including:

  • limit time in the sun, expecially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pant, hats, and sunglasses

children under 6 months: Ask a doctor

Other information

OTHER SAFETY INFORMATION

Other information

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Nitrous Oxide.

Questions?

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

Package display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Look

Coppertone®

SUNSCREEN

water

babies™

Pure & Simple

Whipped

No Fragrance

Parabens, PABA 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

#1

Pediatrician

Recommended

Brand

product labelproduct label

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-740311523-7403-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OXYBENZONE95OOS7VE0YACTIB
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
DICAPRYLYL ETHER77JZM5516ZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
MYRISTYL ALCOHOLV42034O9PUIACT
CHLORPHENESINI670DAL4SZIACT
LAURYL ALCOHOL178A96NLP2IACT
NITROUS OXIDEK50XQU1029IACT

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
8fa0d2d3-79b8-358c-e053-2995a90a94354067928d-9802-72da-e054-00144ff8d46c2019-08-08Exact identifier
spl id: 8fa0d2d3-79b8-358c-e053-2995a90a9435
spl set id: 4067928d-9802-72da-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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