MedPath

Sunscreen

Care One 926.000/926AA Sport Sunscreen Spray SPF 30

Approved
Approval ID

2467dd9b-44ae-4354-9b75-4606204ff042

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 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, Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72476-926
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (9)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NEOPENTYL GLYCOLInactive
Code: QI80HXD6S5
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
AVOBENZONEActive
Quantity: 3 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 15 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 8 g in 100 g
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

principal display panel

CAREONE ®

Compare to Coppertone ® Broad Spectrum SPF 30*

SPORT

Sunscreen Spray SPF 30

UVA/UVB PROTECTION

Broad Spectrum SPF 30

  • Water resistant (80 min)

REEF FRIENDLY**

NET WT. 5.5 OZ (156 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

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: 7/31/2025

ADVERSE REACTION

May stain or damage som fabrics or surfaces

*This product is not manufactured or distributed by Bayer, distributer of Coppertone Suynscreen Spray Sport Broad Spectrum SPF 30.

**Oxybenzone & octinoxate free

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

©2019 S & S Brands, LLC

Quality guaranteed or your money back

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

Purpose

sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

Warnings

For external use only

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 8%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

Inactive ingredients

alcohol denat., neopentyl glycol diheptanoate, polyester-7, tocopherol, fragrance

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/31/2025

Other information

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/31/2025

Do not use

on damaged or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/31/2025

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 - STOP USE SECTION

LOINC: 50566-9Updated: 7/31/2025

Stop use and ask a doctor

rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2025

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: 7/31/2025

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

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