solar plex d55.000/d55aa

solar plex d55.000/d55aa
SPL v4
SPL
SPL Set ID 3da4706e-7c1a-435e-9603-e9aa98432018
Route
topical
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg)
Inactive Ingredients
water diethylhexyl 2,6-naphthalate aluminum starch octenylsuccinate styrene/acrylamide copolymer (500000 mw) butyloctyl salicylate glyceryl monostearate neopentyl glycol diheptanoate silicon dioxide polyester-7 yellow wax carbomer copolymer type a (allyl pentaerythritol crosslinked) glycerin potassium hydroxide chlorphenesin tocopherol benzyl alcohol arachidyl alcohol peg-100 stearate docosanol arachidyl glucoside edetate disodium anhydrous .alpha.-amylcinnamaldehyde sodium ascorbyl phosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-05-03

Adverse Reactions

Manufactured by: Vi-Jon, LLC 8515 Page Ave., St. Louis, MO 63114

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5%


Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions
  • apply liberally 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 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
Adverse Reactions

Manufactured by: Vi-Jon, LLC

8515 Page Ave., St. Louis, MO 63114

Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

water, diethylhexyl 2,6-naphthalate, aluminum starch octenylsuccinate, styrene/acrylates copolymer, butyloctyl salicylate, glyceryl stearate, neopentyl glycol diheptanoate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate

Description

Avobenzone 3% Homosalate 10% Octisalate 5%

Principal Display Panel

SPF 30

NDC 0869-9055-34

SOLAR PLEX ®

MOISTURIZING SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

Water resistant (80 minutes)

Lightweight feel

Oxybenzone, Octinoxate and Octocrylene free

Compare to Coppertone ®Complete Sunscreen Lotion Broad Spectrum SPF 30*

8 FL OZ (236 mL)

Disclaimer

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Lotion SPF 30.

Do Not Use
  • on damaged or broken skin
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

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

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions
  • apply liberally 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 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
Adverse Reactions

Manufactured by: Vi-Jon, LLC

8515 Page Ave., St. Louis, MO 63114

Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

water, diethylhexyl 2,6-naphthalate, aluminum starch octenylsuccinate, styrene/acrylates copolymer, butyloctyl salicylate, glyceryl stearate, neopentyl glycol diheptanoate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate

Principal Display Panel

SPF 30

NDC 0869-9055-34

SOLAR PLEX ®

MOISTURIZING SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

Water resistant (80 minutes)

Lightweight feel

Oxybenzone, Octinoxate and Octocrylene free

Compare to Coppertone ®Complete Sunscreen Lotion Broad Spectrum SPF 30*

8 FL OZ (236 mL)

Disclaimer

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Lotion SPF 30.

Do Not Use (Do not use)
  • on damaged or broken skin
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

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.


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Raw Label Data

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