Studio Selection 924.000/924aa

Studio Selection 924.000/924aa
SPL v10
SPL
SPL Set ID c30c5521-ac6e-4d43-913f-27f11192512c
Route
TOPICAL
Published
Effective Date 2025-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (45 mg) Octocrylene (80 mg)
Inactive Ingredients
Water Aluminum Starch Octenylsuccinate Styrene/acrylamide Copolymer (500000 Mw) Glycerin Polyester-7 Silicon Dioxide Chlorphenesin Arachidyl Alcohol Yellow Wax Benzyl Alcohol Neopentyl Glycol Diheptanoate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Docosanol Tocopherol Arachidyl Glucoside Glyceryl Monostearate Peg-100 Stearate Potassium Hydroxide Edetate Disodium Anhydrous Sodium Ascorbyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-08

Description

Avobenzone 3% Homosalate 10% Octisalate 4.5% Octocrylene 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 4.5% Octocrylene 8%

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
Claims

*This product is not manufactured or distributed by Bayer, distributor of Coppertone ®Sunscreen Lotion Spectrum SPF 50.

Oxybenzone & Octinoxate Free

May stain or damage some fabrics or surfaces

Warnings

For external use only

Directions
  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy from 10  a.m. -2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Do Not Use
  • on damaged or broken skin
Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

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

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Inactive Ingredients

water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

When Using This Product
  • keep out of eyes.  Rinse with water to remove.
Principal Display Panel

STUDIO SELECTION™

SUN

SPORT

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 50

Compare to Coppertone ®Sport Broad Spectrum SPF 50*

SPF 50

  • Water-Resistant (80 minutes)

SWEAT-RESISTANT

FORMULA

8 FL OZ (236 mL)

Stop Use and Ask A Doctor If
  • rash occurs
Keep Out of Reach of Children.

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


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
Claims (claims)

*This product is not manufactured or distributed by Bayer, distributor of Coppertone ®Sunscreen Lotion Spectrum SPF 50.

Oxybenzone & Octinoxate Free

May stain or damage some fabrics or surfaces

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy from 10  a.m. -2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Do Not Use (Do not use)
  • on damaged or broken skin
Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

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

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Inactive Ingredients (inactive ingredients)

water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

When Using This Product (When using this product)
  • keep out of eyes.  Rinse with water to remove.
Principal Display Panel (principal display panel)

STUDIO SELECTION™

SUN

SPORT

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 50

Compare to Coppertone ®Sport Broad Spectrum SPF 50*

SPF 50

  • Water-Resistant (80 minutes)

SWEAT-RESISTANT

FORMULA

8 FL OZ (236 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)