Harris Teeter D43.000/d43aa

Harris Teeter D43.000/d43aa
SPL v3
SPL
SPL Set ID b83ea476-fa32-4405-9ae3-f294836edb62
Route
TOPICAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (120 mg) Octisalate (50 mg)
Inactive Ingredients
Alcohol Diethylhexyl 2,6-naphthalate Diisopropyl Adipate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Butyloctyl Salicylate Neopentyl Glycol Diheptanoate .alpha.-amylcinnamaldehyde Hydroxycitronellal Linalool, (+/-)- .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-19

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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
Purpose

Sunscreen

Dosage and Administration

■ 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

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Flammable

Flammable:Keep away from fire or flame.

After application, wait until product dries before approaching a source of heat or flame, or before smoking

Disclaimer

May stain or damage some fabrics or surfaces

Oxybenzone & Octinoxate free

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray Sport Broad Spectrum SPF 50.

Do Not Use
  • on damaged or broken skin
Adverse Reaction

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Inactive Ingredients

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

Principal Panel Display

Harris Teeter

Sport

Sunscreen Spray

BROAD SPECTRUM SPF 50

Controlled Continuous Spray

Water Resistant (80 Minutes)

Won't Run When You Sweat

Compare to Coppertone ® Sunscreen Spray Sport Broad Spectrum Spf 50*

NET WT 5.5 OZ (156g)

TOGETHER IN EDUCATION

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.
Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 
  • rash occurs

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

■ 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

Warnings and Precautions (34071-1)

For external use only

Purpose

Sunscreen

Flammable

Flammable:Keep away from fire or flame.

After application, wait until product dries before approaching a source of heat or flame, or before smoking

Disclaimer

May stain or damage some fabrics or surfaces

Oxybenzone & Octinoxate free

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray Sport Broad Spectrum SPF 50.

Do Not Use (Do not use)
  • on damaged or broken skin
Adverse Reaction

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

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

Principal Panel Display (Principal panel display)

Harris Teeter

Sport

Sunscreen Spray

BROAD SPECTRUM SPF 50

Controlled Continuous Spray

Water Resistant (80 Minutes)

Won't Run When You Sweat

Compare to Coppertone ® Sunscreen Spray Sport Broad Spectrum Spf 50*

NET WT 5.5 OZ (156g)

TOGETHER IN EDUCATION

When Using This Product (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.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • rash occurs

Advanced Ingredient Data


Raw Label Data

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