Solar Plex 769.000 Rev 1/769aa

Solar Plex 769.000 Rev 1/769aa
SPL v15
SPL
SPL Set ID 791e308f-c6ff-4763-9554-5e8863bfffcb
Route
TOPICAL
Published
Effective Date 2025-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Water Ethylhexyl Palmitate Sorbitol Polyamide-8 (4500 Mw) Benzyl Alcohol Tocopherol Medium-chain Triglycerides Trolamine Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Chlorphenesin Sodium Ascorbyl Phosphate Oleth-3 Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-12

Description

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

Purpose

Sunscreen

Adverse Reactions

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


Medication Information

Purpose

Sunscreen

Adverse Reactions

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

Description

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

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
Warnings

For external use only

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
Disclaimer

May stain or damage some fabrics or surfaces

*Oxybenzone & Octinoxate free

**This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra GUARD Sunscreen Lotion Broad Spectrum SPF 30.

Do Not Use
  • on damaged or broken skin
Other Information
  • Protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Principal Display Panel

SPF 30

REEF FRIENDLY*

NDC 0869-0769-34

SOLAR PLEX™

ULTRA

SUNSCREEN

LOTION

Broad Spectrum SPF 30

Water Resistant (80 minutes)

Hypoallergenic

Dermatologist tested

Compare to Coppertone ®Ultra Guard Sunscreen Lotion**

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 protections 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 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
Disclaimer

May stain or damage some fabrics or surfaces

*Oxybenzone & Octinoxate free

**This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra GUARD Sunscreen Lotion Broad Spectrum SPF 30.

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

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

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Principal Display Panel (Principal display panel)

SPF 30

REEF FRIENDLY*

NDC 0869-0769-34

SOLAR PLEX™

ULTRA

SUNSCREEN

LOTION

Broad Spectrum SPF 30

Water Resistant (80 minutes)

Hypoallergenic

Dermatologist tested

Compare to Coppertone ®Ultra Guard Sunscreen Lotion**

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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