sunscreen — v9

sunscreen

4 Views

Version

v9

Effective date

September 23, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3f7d9277-2b1b-e100-e063-6394a90a0997
Set ID
712acb59-adef-49f6-9e58-1d726ef8b504
Application numbers
M020
Product NDCs
72036-938
Package NDCs
72036-938-14
Original packager NDCs

Names & Manufacturers

Brand names
sunscreen
Generic names
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Manufacturer names
Harris Teeter
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Routes
TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

active ingredients Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 8%
Adverse Reactions (1)

Sequence 1

ADVERSE REACTION PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 1-800-432-6111 or harristeeter.com
Do Not Use (1)

Sequence 1

do not use on damaged or broken skin
Dosage And Administration (1)

Sequence 1

direction ■ 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 (1)

Sequence 1

inactive ingredients alcohol denat., acrylates/octylacrylamide copolymer, glycerin, triethanolamine, tocopherol, butyloctyl salicylate, fragrance
Indications And Usage (1)

Sequence 1

uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Conrol Center right away.
Package Label Principal Display Panel (1)

Sequence 1

principal display panel Harris Teeter™ Sport Sunscreen Spray BROAD SPECTRUM SPF 50 50 Controlled Continuous Spray Water Resistant (80 Minutes) Won't Run When You Sweat REEF FRIENDLY* BPA Free Compare to Coppertone ® Sunscreen Spray Sport Broad Spectrum SPF 50** NET WT 5.5 OZ (156 g) TOGETHER IN EDUCATION image description
Purpose (1)

Sequence 1

purpose sunscreen
Spl Product Data Elements (1)

Sequence 1

sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ALCOHOL STEAROXYTRIMETHYLSILANE GLYCERIN TROLAMINE TOCOPHEROL BUTYLOCTYL SALICYLATE AVOBENZONE AVOBENZONE
Spl Unclassified Section (4)

Sequence 1

Flammable Keep away from fire or flame. after application, wait until product dries before approaching a source of heat or flame, or before smoking

Sequence 2

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

Sequence 3

Claims May stain or damage some fabrics of surfaces *Oxybenzone & Octinoxate free

Sequence 4

Disclaimer **This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 50.
Stop Use (1)

Sequence 1

stop use and ask a doctor if rash occurs
Warnings (1)

Sequence 1

warnings For external use only
When Using (1)

Sequence 1

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 120ºF.

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['sunscreen'],
 'generic_name': ['AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Harris Teeter'],
 'package_ndc': ['72036-938-14'],
 'product_ndc': ['72036-938'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3f7d9277-2b1b-e100-e063-6394a90a0997'],
 'spl_set_id': ['712acb59-adef-49f6-9e58-1d726ef8b504'],
 'substance_name': ['AVOBENZONE', 'HOMOSALATE', 'OCTISALATE', 'OCTOCRYLENE'],
 'unii': ['G63QQF2NOX', 'V06SV4M95S', '4X49Y0596W', '5A68WGF6WM']}