Studio Selection D50aa/d50.000

Studio Selection D50aa/d50.000
SPL v3
SPL
SPL Set ID 1673b8b1-08ad-40a5-8180-93333a8edb67
Route
TOPICAL
Published
Effective Date 2025-09-26
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 Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aluminum Starch Octenylsuccinate Glycerin Polyester-7 Silicon Dioxide Chlorphenesin Arachidyl Alcohol Yellow Wax Neopentyl Glycol Diheptanoate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Docosanol Tocopherol Arachidyl Glucoside Glyceryl Monostearate Peg-100 Stearate Potassium Hydroxide Benzyl Alcohol Edetate Disodium Anhydrous Sodium Ascorbyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-05

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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
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, 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

OCTINOXATE FREE, OXYBENZONE FREE

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

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIGDE

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 12%

Octisalate 5%

Inactive Ingredients

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

SUNSCREEN LOTION

Broad Spectrum SPF 50

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

SPF 50

Dermatologist-Tested

Hypoallergenic

Water-Resistant (80 minutes)

Banana Scent

6 FL OZ (177 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 Center 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
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, 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

OCTINOXATE FREE, OXYBENZONE FREE

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

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIGDE

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 12%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

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

SUNSCREEN LOTION

Broad Spectrum SPF 50

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

SPF 50

Dermatologist-Tested

Hypoallergenic

Water-Resistant (80 minutes)

Banana Scent

6 FL OZ (177 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 Center right away.


Advanced Ingredient Data


Raw Label Data

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