FDA.reportPublic FDA data

Care One D54.000/D54AA Moisturizing Sunscreen Lotion SPF 50

Manufacturer
Retail Business Service, LLC | Nice-Pak Products, LLC
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:37:19

Label at a glance#

ProductMoisturizing Sunscreen SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure14 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protections 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 apply to all skin exposed to the sun 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 protecti...

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protections 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
  • apply to all skin exposed to the sun
  • 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-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, neopentyl glycol diheptanoate, glyceryl stearate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Disclaimer

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, the owner of the registered trademark Coppertone ® Complete Sunscreen Lotion SPF 50.

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone

Compare to Coppertone Complete Sunscreen Lotion SPF 50*

SUNSCREEN Lotion

SPF 50

UVA/UVB SUNSCREEN

Broad Spectrum SPF 50

  • Water resistant (80 min)
  • Moisturizes
  • Hypoallergenic

8FL OZ (236 mL)

picpic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-954-05Moisturizing Sunscreen SPF 50207 mL in 1 TUBELOTION2075
72476-954-34Moisturizing Sunscreen SPF 50236 mL in 1 BOTTLELOTION2365

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-95472476-954-34, 72476-954-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYESTER-70841698D2FIACT
YELLOW WAX2ZA36H0S2VIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
CHLORPHENESINI670DAL4SZIACT
TOCOPHEROLR0ZB2556P8IACT
BENZYL ALCOHOLLKG8494WBHIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
PEG-100 STEARATEYD01N1999RIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Service, LLC9de8b6b1-024b-4b71-96e6-fea68088d3ab2026-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 72476-954-05
ndc (package): 72476-954-34
ndc (product): 72476-954
ndc11 (package): 72476095434
ndc11 (package): 72476095405
spl id: 4a2cd481-7363-9932-e063-6294a90aae1a
spl set id: 9de8b6b1-024b-4b71-96e6-fea68088d3ab

Reported adverse events (FAERS/openFDA)#

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