Sunscreen

Manufacturer
American Sales Company | Vi-Jon
Effective date
2023-02-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:35:30

Label at a glance#

ProductSunscreen
Active ingredientAvobenzone, Homosalate, Octisalate, OCTOCRYLENE, Oxybenzone
Label structure13 sections

Dosage and administration

apply liberally 15 minutes before sun exposure 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 7%

Oxybenzone 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center Right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • 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 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-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • protect the product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopherol, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Water Babies Broad Spectrum SPF 50

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-846-9949

(c) 2018 S&S brands, LLC

Quality guaranteed or your money back

752.000/752AB

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Care One

Baby Sunscreen Lotion

Compare to Coppertone sunscreen lotion water babies SPF 50

SPF 50 UVA/UVB protection

Broad Spectrum SPF 50

Compare to Coppertone Water Babies

Water Resistant (80 minutes)

8 FL OZ (236 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-75241520-752-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
6a8a85be-125e-49c1-86fd-adaf7486454cffb97784-7fe5-4d45-92fa-e6d11aa462512023-10-23WarningsExact identifier
spl set id: ffb97784-7fe5-4d45-92fa-e6d11aa46251

Reported adverse events (FAERS/openFDA)#

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