MedPath

Avobenzone, Homosalate, Octisalate

Rite Aid D41.000/D41AA Sport Sunscreen Spray SPF 30

Approved
Approval ID

7b100856-8096-4431-90c3-837ba4406fc6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

Rite Aid

DUNS: 014578892

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 Code11822-0941
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (13)

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
.ALPHA.-AMYLCINNAMALDEHYDEInactive
Code: WC51CA3418
Classification: IACT
HYDROXYCITRONELLALInactive
Code: 8SQ0VA4YUR
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: 6/9/2025

Principal display panel

Compare to Coppertone ®Sunscreen Spray Sport Broad Spectrum SPF 30*

SPORT

WATER RESISTANT (80 MINUTES)

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 30

Avobenzone 3%

Homosalate 10%

Octisalate 5%

30

NET WT 5.5 OZ (156 g)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/9/2025

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: 6/9/2025

Adverse Reaction

DISTRIBUTED BY:

RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION GUARENTEE:

if you're not satisfied, we'll happily refund your money.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/9/2025

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/9/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 6/9/2025

Warnings

For external use only

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/9/2025

Disclaimers

May stain or damage some fabrics or surfaces

*This product is not manufactured of distributed by Beiersdorf AG, distributer of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 30.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/9/2025

Do not use

on damaged or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/9/2025

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: 6/9/2025

Stop use and ask a doctor

rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/9/2025

Keep out of reach of children.

If swallowed, seek immediate medical attention or call a poison control center.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/9/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/9/2025

Inactive ingredients

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

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Avobenzone, Homosalate, Octisalate - FDA Drug Approval Details