MedPath

Sunscreen

Harris Teeter 924.000/924AA Sport Sunscreen Lotion SPF 50

Approved
Approval ID

fc45bdbb-e5c9-42b2-a93a-06785cb63654

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Harris Teeter

DUNS: 047279351

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 Code72036-924
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (24)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)Inactive
Code: 5Z4DPO246A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
ARACHIDYL ALCOHOLInactive
Code: 1QR1QRA9BU
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)Inactive
Code: 59TL3WG5CO
Classification: IACT
DOCOSANOLInactive
Code: 9G1OE216XY
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
ARACHIDYL GLUCOSIDEInactive
Code: 6JVW35JOOJ
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
SODIUM ASCORBYL PHOSPHATEInactive
Code: 836SJG51DR
Classification: IACT
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
HOMOSALATEActive
Quantity: 100 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 45 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 80 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/13/2025

PRINCIPAL DISPLAY PANEL

Harris Teeter

Sport

Sunscreen

Lotion

BROAD SPECTRUM SPF 50

Water Resistant

(80 Minutes)

Won't Run When You Sweat

REEF FRIENDLY*

BPA Free

Compare to Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 50**

8 FL OZ (236 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/13/2025

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: 2/13/2025

ADVERSE REACTIONS

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 of harristeeter.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/13/2025

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/13/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 2/13/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 2/13/2025

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 2/13/2025

When using this product

  • keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 2/13/2025

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/13/2025

Keep out of reach of children.

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/13/2025

Disclaimer

**This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 50.

May stain or damage some fabrics or surfaces

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/13/2025

Directions

■ apply liberally {and evenly} 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 SAFETY INFORMATION

LOINC: 60561-8Updated: 2/13/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/13/2025

inactive ingredients

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

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Sunscreen - FDA Drug Approval Details