FDA.reportPublic FDA data

Waterbabies Lotion Spray SPF 50 UI 1614232

Manufacturer
Bayer HealthCare LLC.
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:57:23

Label at a glance#

ProductCoppertone Water Babies
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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 ■ shake well before each use ■ apply liberally 15 minutes before sun exposure and rub into skin ■ 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 s...

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

Flammable: 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.
■ 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 - 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

■ shake well before each use

■ apply liberally 15 minutes before sun exposure and rub into skin

■ 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

OTHER SAFETY INFORMATION

Other information

■ protect this product from excessive heat and direct sun

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT SECTION

Inactive ingredients water, dimethyl ether, aloe barbadensis leaf juice, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, VP/eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, fragrance, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA

OTC - QUESTIONS SECTION

Questions? 1-866-288-3330

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Improved Formula

Coppertone®

SUNSCREEN SPRAY

water

babies

LOTION SPRAY

Hypoallergenic & Gentle 50

#1 Pediatrician

Recommended brand

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 6 OZ (170 g)

Bottle 6 oz.Bottle 6 oz.

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-743711523-7437-1, 11523-7437-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TOCOPHEROLR0ZB2556P8IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ALOE VERA LEAFZY81Z83H0XIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
2'-HYDROXYACETOPHENONE3E533Z76W0IACT
EDETATE DISODIUM7FLD91C86KIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIMETHYL ETHERAM13FS69BXIACT

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
9831d790-806f-69d9-e053-2a95a90a72ee76c6da92-a894-9172-e053-2991aa0a50e82019-11-25WarningsExact identifier
spl id: 9831d790-806f-69d9-e053-2a95a90a72ee
spl set id: 76c6da92-a894-9172-e053-2991aa0a50e8

Reported adverse events (FAERS/openFDA)#

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