Rite Aid D49.000/d49aa

Rite Aid D49.000/d49aa
SPL v4
SPL
SPL Set ID 9dcc8aa2-9073-4e3b-b13c-ffaff0ad9473
Route
TOPICAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-25

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

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%

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
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

Do Not Use

on damaged or broken skin

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.

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, tocopheryl acetate

Principal Display Panel

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

BROAD SPECTRUM SPF 50

Avobenzone 3%

Homosalate 12%

Octisalate 5%

50

NET WT 5.5 OZ (156 g)

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.

Stop Use and Ask A Doctor If 

rash occurs


Structured Label Content

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
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

Do Not Use (Do not use)

on damaged or broken skin

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.

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, tocopheryl acetate

Principal Display Panel (Principal display panel)

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

BROAD SPECTRUM SPF 50

Avobenzone 3%

Homosalate 12%

Octisalate 5%

50

NET WT 5.5 OZ (156 g)

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.

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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