Studio Selection D47.001/d47aa

Studio Selection D47.001/d47aa
SPL v4
SPL
SPL Set ID ce9a2139-c5c2-43e2-bd51-1f14ace594d9
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 Aloe Vera Leaf Glycerin Polyester-7 Silicon Dioxide Chlorphenesin Benzyl Alcohol Arachidyl Alcohol Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Neopentyl Glycol Diheptanoate Docosanol Tocopherol Yellow Wax Arachidyl Glucoside Potassium Hydroxide Glyceryl Monostearate Peg-100 Stearate Edetate Disodium Anhydrous Sodium Ascorbyl Phosphate .alpha.-hexylcinnamaldehyde Isomethyl-.alpha.-ionone Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-31

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 rist, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy 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

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

OCTINOXATE FREE

OXYBENZONE FREE

May stain or damage some fabrics or surfaces

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 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, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol

Principal Panel Display

STUDIO SELECTION ®

SUN

SUNSCREEN LOTION FOR 

babies

BROAD SPECTRUM SPF 50

Compare to Coppertone ®Water Babies ®Broad Spectrum SPF 50*

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

SPF 50

Pediatrician-Tested

Hypoallergenic

8 FL OZ (236 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 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 rist, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy 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

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

OCTINOXATE FREE

OXYBENZONE FREE

May stain or damage some fabrics or surfaces

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 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, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol

Principal Panel Display

STUDIO SELECTION ®

SUN

SUNSCREEN LOTION FOR 

babies

BROAD SPECTRUM SPF 50

Compare to Coppertone ®Water Babies ®Broad Spectrum SPF 50*

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

SPF 50

Pediatrician-Tested

Hypoallergenic

8 FL OZ (236 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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