FDA.reportPublic FDA data

Coppertone Waterbabies Whipped SPF 50

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:54:36

Label at a glance#

ProductCoppertone Waterbabies Whipped SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
Label structure10 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,...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 9%, Octisalate 4.5%,

Octocrylene 9%

OTC - PURPOSE SECTION

Purpose

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 SECTION

Warnings
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.

■ 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.

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

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 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

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 INGREDIENT SECTION

Inactive ingredients water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, behenyl alcohol, glycerin, dicaprylyl ether, nitrous oxide, microcrystalline cellulose, glyceryl stearate, cetyl alcohol, sodium ascorbyl phosphate, tocopherol, lecithin, palmitic acid, stearic acid, myristyl alcohol, lauryl alcohol, caprylyl glycol, cellulose gum, hydroxyacetophenone, 1,2,-hexanediol, butylated PVP, disodium EDTA

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

Package label display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coppertone®
SUNSCREEN
water babies®
Whipped

Soft & Gentle 50

Fast Absorbing

#1 Pediatrician

Recommended brand

No Dyes, PABA, Oxybenzone
Water Resistant (80 Minutes)
Broad Spectrum SPF 50
NET WT 5 OZ (142 g)

Label 5 oz. canLabel 5 oz. can

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-745311523-7453-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICAPRYLYL ETHER77JZM5516ZIACT
NITROUS OXIDEK50XQU1029IACT
MYRISTYL ALCOHOLV42034O9PUIACT
AVOBENZONEG63QQF2NOXACTIB
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
WATER059QF0KO0RIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
PALMITIC ACID2V16EO95H1IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TOCOPHEROLR0ZB2556P8IACT
LAURYL ALCOHOL178A96NLP2IACT
CAPRYLYL GLYCOL00YIU5438UIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HOMOSALATEV06SV4M95SACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML · Source PDF

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
994b8b0f-c1e5-f461-e053-2a95a90a447b909f0be1-676d-1c18-e053-2a95a90a7a0f2019-12-09WarningsExact identifier
spl id: 994b8b0f-c1e5-f461-e053-2a95a90a447b
spl set id: 909f0be1-676d-1c18-e053-2a95a90a7a0f

Reported adverse events (FAERS/openFDA)#

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