Studio Select D49.000/d49aa

Studio Select D49.000/d49aa
SPL v3
SPL
SPL Set ID 9b7249e4-4c1f-40e7-a657-d40c53d9317f
Route
TOPICAL
Published
Effective Date 2025-08-15
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.-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

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

Keep away from fire or flame. 

  • After application, wait until product dries before approaching a source of heat or flame, or before smoking
Do Not Use
  • on damaged or broken skin
Disclaimers

May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXYBENZONE FREE

*This product is not manufactured or distributed by Sun Bum LLC, distributor of Sun Bum Premium Moisturizing Sunscreen Spray Broad Spectrum SPF 50.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

DSP-TN-21091

DSP-MO-20087

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

STUDIO SELECTION ®

SUN

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

Compare to Sun Bum ®Sunscreen Spray Broad Spectrum SPF 50*

SPF 50

Dermatologist-Tested

Hypoallergenic

Water-Resistant (80 minutes)

Banana Scent

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, get medical help or contact 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

Keep away from fire or flame. 

  • After application, wait until product dries before approaching a source of heat or flame, or before smoking
Do Not Use (Do not use)
  • on damaged or broken skin
Disclaimers

May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXYBENZONE FREE

*This product is not manufactured or distributed by Sun Bum LLC, distributor of Sun Bum Premium Moisturizing Sunscreen Spray Broad Spectrum SPF 50.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

DSP-TN-21091

DSP-MO-20087

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)

STUDIO SELECTION ®

SUN

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

Compare to Sun Bum ®Sunscreen Spray Broad Spectrum SPF 50*

SPF 50

Dermatologist-Tested

Hypoallergenic

Water-Resistant (80 minutes)

Banana Scent

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, 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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