Studio Selection D36.000/d36aa

Studio Selection D36.000/d36aa
SPL v4
SPL
SPL Set ID ef48288b-533f-4924-ba12-fc8cb83643d4
Route
TOPICAL
Published
Effective Date 2025-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg)
Inactive Ingredients
Alcohol Diisopropyl Adipate Diethylhexyl 2,6-naphthalate Butyloctyl Salicylate Neopentyl Glycol Diheptanoate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Benzyl Benzoate Butylphenyl Methylpropional .beta.-citronellol, (r)- .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-29

Description

Avobenzone 3% Homosalate 15% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% 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: Keep away from fire or flame.

  • after application, wait until product dries before approaching a source of heat or flame, or before smoking
Directions
  • 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
Do Not Use
  • on damaged or broken skin
Adverse Events

May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXYBENZONE FREE

DISTRIBUTED BY OLD 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 15%

Octisalate 5%

Inactive Ingredients

alcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

Principal Panel Display

STUDIO SELECTION ®

SUN

SHEER TOUCH 

SUNSCREEN MIST

BROAD SPECTRUM SPF 100

  • Water-Resistant (80 minutes)
  • Absorbs quickly

SPF 100

UVA/UVB Sunscreen

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 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: Keep away from fire or flame.

  • after application, wait until product dries before approaching a source of heat or flame, or before smoking
Directions
  • 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
Do Not Use (Do not use)
  • on damaged or broken skin
Adverse Events (Adverse events)

May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXYBENZONE FREE

DISTRIBUTED BY OLD 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 (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

alcohol denat., diisopropyl adipate, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, neopentyl glycol diheptanoate, acrylates/octylacrylamide copolymer, fragrance, benzyl benzoate, butylphenyl methylpropional, citronellol, tocopheryl acetate

Principal Panel Display

STUDIO SELECTION ®

SUN

SHEER TOUCH 

SUNSCREEN MIST

BROAD SPECTRUM SPF 100

  • Water-Resistant (80 minutes)
  • Absorbs quickly

SPF 100

UVA/UVB Sunscreen

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 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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