Studio Selection 983.000/983aa

Studio Selection 983.000/983aa
SPL v7
SPL
SPL Set ID 00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a
Route
TOPICAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Alcohol Octyldodecyl Neopentanoate Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Diethylhexyl 2,6-naphthalate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-18

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

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

Disclaimer

May stain or damage some fabrics of surfaces

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Beach Defense Water + Sun Protection Sunscreen Spray Broad Spectrum SPF 70.

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 the container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

alcohol denat., octyldodecyl neopentanoate, acrylates/octylacrylamide copolymer, diethylhexyl 2,6-naphthalate, tocopheryl acetate, fragrance

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.
Principal Display Panel

STUDIO SELECTION™

SUN

BEACH GUARD

SUN + WATER

Protection

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 70

Compare to Neutrogena ®Beach Defense Sunscreen Spray

  • Water-Resistant (80 minutes)
  • UVA/UVB protection

SPF 70

Octinoxate & Oxybenzone Free

Dermatologist Tested

NET WT 6.5 OZ (184 g)

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

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


Structured Label Content

Uses (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 (purpose)

sunscreen

Warnings (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

Disclaimer

May stain or damage some fabrics of surfaces

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Beach Defense Water + Sun Protection Sunscreen Spray Broad Spectrum SPF 70.

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 the container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (inactive ingredients)

alcohol denat., octyldodecyl neopentanoate, acrylates/octylacrylamide copolymer, diethylhexyl 2,6-naphthalate, tocopheryl acetate, fragrance

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.
Principal Display Panel (principal display panel)

STUDIO SELECTION™

SUN

BEACH GUARD

SUN + WATER

Protection

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 70

Compare to Neutrogena ®Beach Defense Sunscreen Spray

  • Water-Resistant (80 minutes)
  • UVA/UVB protection

SPF 70

Octinoxate & Oxybenzone Free

Dermatologist Tested

NET WT 6.5 OZ (184 g)

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 Conrol Center right away.


Advanced Ingredient Data


Raw Label Data

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