Solar Plex D47aa/d47.001

Solar Plex D47aa/d47.001
SPL v2
SPL
SPL Set ID a4b9d7c0-dc09-4f0e-8b65-90ba180552bf
Route
TOPICAL
Published
Effective Date 2025-05-09
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 2024-05-06

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
Disclaimer

May stain or damage some fabrics or surfaces

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

Do Not Use
  • on damaged or broken skin
Adverse Reaction

Distributed by:

Consumer Product Partners, LLC

ST. Louis MO 63114

1-888-593-0593

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

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Principal display Panel

SPF 50

SOLAR PLEX ®

SUNSCREEN LOTION FOR BABIES

Broad Spectrum SPF 50

Water resistant (80 minutes)

With Aloe and Vitamin E

Oxybenzone, Octinoxate, Octocrylene and Dye free

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

8 FL OZ (236 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 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
Disclaimer

May stain or damage some fabrics or surfaces

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

Do Not Use (Do not use)
  • on damaged or broken skin
Adverse Reaction (Adverse reaction)

Distributed by:

Consumer Product Partners, LLC

ST. Louis MO 63114

1-888-593-0593

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

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Principal display Panel (Principal Display Panel)

SPF 50

SOLAR PLEX ®

SUNSCREEN LOTION FOR BABIES

Broad Spectrum SPF 50

Water resistant (80 minutes)

With Aloe and Vitamin E

Oxybenzone, Octinoxate, Octocrylene and Dye free

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

8 FL OZ (236 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 right away.


Advanced Ingredient Data


Raw Label Data

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