Moisturizing Sunscreen SPF 50
Solar Plex D54.000/D54AA Moisturizing Sunscreen Lotion SPF 50
1256527f-ea9a-4338-8f09-0f256b49962d
HUMAN OTC DRUG LABEL
May 12, 2025
Consumer Product Partners, LLC
DUNS: 119091520
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Avobenzone, Homosalate, Octisalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (26)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Panel Display
SPF 50
SOLAR PLEX ®
MOISTURIZING SUNSCREEN LOTION
BROAD SPECTRUM SPF 50
Water resistant (80 minutes)
Lightweight feel
Oxybenzone, Octinoxate and Octocrylene free
Compare to Coppertone ®Complete Sunscreen Lotion Broad Spectrum SPF 50*
8 FL OZ (236 mL)
INDICATIONS & USAGE SECTION
Uses
- helps prevent sunburn
- if used as directed with other sun protections measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun
ADVERSE REACTIONS SECTION
Adverse Reactions
Manufactured by: Vi-Jon, LLC
8515 Page Ave., St. Louis, MO 63114
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Avobenzone 3%
Homosalate 12%
Octisalate 5%
OTC - PURPOSE SECTION
Purpose
Sunscreen
WARNINGS SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use
- on damaged or broken skin
OTC - WHEN USING SECTION
When using this product
- keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Other Information
- Protect the product in this container from excessive heat and direct sun
INACTIVE INGREDIENT SECTION
Inactive ingredients
water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, neopentyl glycol diheptanoate, glyceryl stearate, 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
SPL UNCLASSIFIED SECTION
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 50.