rite aid d42.000/d42aa

rite aid d42.000/d42aa
SPL v3
SPL
SPL Set ID 975f0f29-df30-474c-81a0-c569b705fd08
Route
topical
Published
Effective Date 2025-06-09
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 2023-07-25

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%


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

Other Information

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

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

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Principal Display Panel

Compare to Coppertone ® Sunscreen Spray Kids Broad Spectrum SPF 50*

KIDS

WATER RESISTANT 

SUNSCREEN SPRAY

Avobenzone 3%

Homosalate 12%

Octisalate 5%

OCTOCRYLENE FREE

BROAD SPECTRUM SPF 50

NET WT 5.5 OZ (156 g)

Do Not Use

on damaged or broken skin

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
Disclaimers

May stain or damage some fabrics or surfaces

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

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.

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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

Stop Use and Ask A Doctor If 

rash occurs


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

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
Purpose

Sunscreen

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

Other Information (Other information)

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

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 Display Panel (Principal display panel)

Compare to Coppertone ® Sunscreen Spray Kids Broad Spectrum SPF 50*

KIDS

WATER RESISTANT 

SUNSCREEN SPRAY

Avobenzone 3%

Homosalate 12%

Octisalate 5%

OCTOCRYLENE FREE

BROAD SPECTRUM SPF 50

NET WT 5.5 OZ (156 g)

Do Not Use (Do not use)

on damaged or broken skin

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
Disclaimers

May stain or damage some fabrics or surfaces

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

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.

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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, get medical help or contact 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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