Studio Selection D54.000/d55aa

Studio Selection D54.000/d55aa
SPL v5
SPL
SPL Set ID 32036e41-2414-4498-8e1c-61511abf7a32
Route
TOPICAL
Published
Effective Date 2025-06-25
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
Water Diethylhexyl 2,6-naphthalate Butyloctyl Salicylate Styrene/acrylamide Copolymer (500000 Mw) Aluminum Starch Octenylsuccinate Neopentyl Glycol Diheptanoate Glyceryl Monostearate Silicon Dioxide Polyester-7 Yellow Wax Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Glycerin Potassium Hydroxide Chlorphenesin Tocopherol Benzyl Alcohol Arachidyl Alcohol Peg-100 Stearate Docosanol Arachidyl Glucoside Edetate Disodium Anhydrous .alpha.-amylcinnamaldehyde Sodium Ascorbyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-24

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen

Adverse Reactions

DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030 OCTINOXATE FREE OXYBENZONE FREE


Medication Information

Purpose

Sunscreen

Adverse Reactions

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

OCTINOXATE FREE

OXYBENZONE FREE

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings

For external use only

Directions
  • apply liberally 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 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
Do Not Use
  • on damaged or broken skin
Disclaimers

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Lotion SPF 50.

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

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Inactive Ingredients

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, neopentyl glycol diheptanoate, glyceryl stearate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate

Principal Panel Display

STUDIO SELECTION ®

SUN

MOISTURIZING SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

Compare to Coppertone ®Complete Sunscreen Lotion Broad Spectrum SPF 50*

  • Water-resistant (80 minutes)
  • Lightweight feel

SPF 50

Dermatologist-Tested

UVA/UVB Sunscreen

3 FL OZ (89 mL)

When Using This Product
  • keep out of eyes. Rinse with water to remove.
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 Center right away.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 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 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
Do Not Use (Do not use)
  • on damaged or broken skin
Disclaimers

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Lotion SPF 50.

Adverse Reactions

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

OCTINOXATE FREE

OXYBENZONE FREE

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)

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, neopentyl glycol diheptanoate, glyceryl stearate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate

Principal Panel Display

STUDIO SELECTION ®

SUN

MOISTURIZING SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

Compare to Coppertone ®Complete Sunscreen Lotion Broad Spectrum SPF 50*

  • Water-resistant (80 minutes)
  • Lightweight feel

SPF 50

Dermatologist-Tested

UVA/UVB Sunscreen

3 FL OZ (89 mL)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
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 Center right away.


Advanced Ingredient Data


Raw Label Data

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