FDA.reportPublic FDA data

Studio Selection D42.000/D42AA Sunscreen Spray for Kids SPF 50

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:48:36

Label at a glance#

ProductAvobenzone, Homosalate, Octisalate
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure15 sections

Indications and 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

Dosage and administration

■ spray liberally and spread evenly by hand 15 minutes before sun exposure ■ apply to all skin exposed to the sun ■ hold container 4 to 6 inches from the skin to apply ■ do not spray directly into face. Spray on hands then apply to face. ■ do not apply in windy conditions ■ use in a well-ventilated area and avoid inhalation ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Flammable

SPL UNCLASSIFIED SECTION

  • Flammable: keep away from fire or flame. 
  • After application, wait until product dries before approaching a source of heat or flame, or before smoking

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.
  • contents under pressure.  Do not puncture or incinerate.  Do not store at temperature above 120°F.

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

■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area and avoid inhalation
■ 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

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Disclaimer

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXBENZONE FREE

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

Adverse reaction

ADVERSE REACTIONS SECTION

DSP-TN-21091 DSP-MO-20087

100% Satisfaction Guarnteed!

(888) 309-9030

DISTRIBUTED BY: Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDO SELECTION ®

SUN

SUNSCREEN SPRAY FOR KIDS

BROAD SPECTRUM SPF 50

Compare to Coppertone ®Sunscreen Spray Kids Broad Spectrum SPF 50*

  • WATER RESISTANT (80 MINUTES)
  • UVA/UVB sunscreen

SPF 50

Family Size

NET WT 11 OZ (312 g)

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-442-14Avobenzone, Homosalate, Octisalate156 g in 1 BOTTLE, SPRAYSPRAY1565
55910-442-39Avobenzone, Homosalate, Octisalate312 g in 1 BOTTLE, SPRAYSPRAY3125

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-44255910-442-14, 55910-442-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW)7LL6SY9YFVIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
LINALOOL, (+/-)-D81QY6I88EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 55910-442-14
ndc (package): 55910-442-39
ndc (product): 55910-442
ndc11 (package): 55910044214
ndc11 (package): 55910044239
spl id: 4c110e1b-5525-3dea-e063-6294a90a97f6
spl set id: b3d2da09-d9c9-4c27-82fe-a434ece2f099

Reported adverse events (FAERS/openFDA)#

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