MedPath

Sport Sunscreen SPF 50

Care One D56.000/D56AA Moisturizing Sunscreen Spray SPF 30

Approved
Approval ID

3a4d1971-870c-474b-b50a-36ce6299328e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

RETAIL BUSINESS SERVICES , LLC

DUNS: 967989935

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72476-956
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (11)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIETHYLHEXYL 2,6-NAPHTHALATEInactive
Code: I0DQJ7YGXM
Classification: IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW)Inactive
Code: 7LL6SY9YFV
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
LINALOOL, (+/-)-Inactive
Code: D81QY6I88E
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 100 mg in 1 g
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Principal panel display

CAREone ®

Compare to the SPF of Coppertone ®Broad Spectrum SPF 30*

SUNSCREEN SPRAY

SPF 30

UVA/UVB SUNSCREEN

Broad Spectrum SPF 30

  • Water resistant (80 min)
  • Hypoallergenic

NET WT 5.5 OZ (156 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/20/2025

Adverse Reaction

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.

Empty Before Recycling

METAL CAN

how2recycle.info

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/20/2025

When using this product

  • keep out of eyes. Rinse with water to remove.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/20/2025

Do not use

on damaged or broken skin

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings

For external use only

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/20/2025

Disclaimer

May stain or damage some fabrics or surfaces

*This product is not being compared to Coppertone ® Complete Sunscreen Spray SPF 30 for any other purposes and this product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Spray SPF 30.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/20/2025

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/20/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

Directions

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area and avoid inhalation
  • 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/20/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Inactive ingredients

alcohol denat., diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, fragrance, linalool, tocopheryl acetate

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