FDA.reportPublic FDA data

Studio Selection 940.000/940AA Ultra Sunscreen Lotion SPF 50

Manufacturer
Old East Main CO. | Consumer Product Partners, LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:35:00

Label at a glance#

ProductSUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 sections

Dosage and administration

■ 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 an...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, fragrance, benzyl alcohol, disodium EDTA

Disclaimers

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

Oxybenzone & Oxtinoxate free

*This product is not manufactured or distributed by Bayer, distributor of Coppertone ®Sunscreen Lotion Ultra Guard Broad Spectrum SPF 50.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO SELECTION™

SUN

ULTRA SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

Compare to Coppertone ®Ultra Guard ®Broad Spectrum SPF 50*

  • Water-Resistant (80 minutes)
  • With moisturizers and Vitamin E

SPF 50

Dermatologist-Tested

UVA/UVB Protection

3 FL OZ (89 mL)

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-94055910-940-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
POLYESTER-70841698D2FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CHLORPHENESINI670DAL4SZIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
YELLOW WAX2ZA36H0S2VIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
DOCOSANOL9G1OE216XYIACT
TOCOPHEROLR0ZB2556P8IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
494dfed4-de14-3ab7-e063-6294a90ac52d75d5fa3b-c1fb-4ba4-baaf-bb714a4d18332026-01-26Warnings, Adverse reactionsExact identifier
spl set id: 75d5fa3b-c1fb-4ba4-baaf-bb714a4d1833

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.