Studio Selection 139.000/139aa Rev 1

Studio Selection 139.000/139aa Rev 1
SPL v2
SPL
SPL Set ID 42258ebe-e3cc-4d70-e063-6294a90a9651
Route
TOPICAL
Published
Effective Date 2025-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Homosalate
Inactive Ingredients
Neopentyl Glycol Diheptanoate Hydroxycitronellal Diethylhexyl 2,6-naphthalate Diisopropyl Adipate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Alcohol .alpha.-tocopherol Acetate Butyloctyl Salicylate .alpha.-amylcinnamaldehyde Linalool, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-27

Description

Avobenzone 3% Homosalate 5% Octisalate 5%

Purpose

Sunscreen

Adverse Reactions

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


Medication Information

Purpose

Sunscreen

Adverse Reactions

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

Description

Avobenzone 3% Homosalate 5% 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

Flammable: Do not use near heat, flame, or while smoking.

Directions
  • apply liberally 15 minutes before sun exposure
  • 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 ® Sunscreen Spray Tanning Broad Spectrum SPF 15.

Other Information
  • protect the product from excessive heat and direct sun
  • avoid long term storage above 40ºC (104ºF)
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Inactive Ingredients

alcohol denat., diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Principal Display Panel

STUDIO SELECTION ®

SUN

TANNING

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 15

Compare to Coppertone ® Sunscreen Spray Tanning Broad Spectrum SPF 15*

  • Water-Resistant (80 minutes)
  • Moisturizes skin

SPF 15

Non-greasy

Lightweight Feel

NET WT 5.5 OZ (156 g)

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.
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

Flammable: Do not use near heat, flame, or while smoking.

Directions
  • apply liberally 15 minutes before sun exposure
  • 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 ® Sunscreen Spray Tanning Broad Spectrum SPF 15.

Adverse Reactions

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 from excessive heat and direct sun
  • avoid long term storage above 40ºC (104ºF)
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

alcohol denat., diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Principal Display Panel

STUDIO SELECTION ®

SUN

TANNING

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 15

Compare to Coppertone ® Sunscreen Spray Tanning Broad Spectrum SPF 15*

  • Water-Resistant (80 minutes)
  • Moisturizes skin

SPF 15

Non-greasy

Lightweight Feel

NET WT 5.5 OZ (156 g)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.
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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