FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:48:28

Label at a glance#

ProductSUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 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

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 ...

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 15%
Octisalate 5%
Octocrylene 10%

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

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, beeswax, cyclopentasiloxane, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, chlorphenesin, benzyl alcohol, triethanolamine, disodium EDTA, BHT

Disclaimers

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena ®Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 100+.

Oxybenzone & Octinoxate free

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

SHEER TOUCH 

SUNSCREEN LOTION

BROAD SPECTRUM SPF 100

Compare to Neutrogena ®Ultra Sheer Sunscreen Broad Spectrum SPF 100+*

  • Water-Resistant (80 minutes)
  • Lightweight, Clean skin feel

SPF 100

Dermatologist-Tested

UVA/UVB Protection

3 FL OZ (88 mL)

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-877-21SUNSCREEN88 mL in 1 BOTTLE, PLASTICLOTION8812

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-87755910-877-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
YELLOW WAX2ZA36H0S2VIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CHLORPHENESINI670DAL4SZIACT
BENZYL ALCOHOLLKG8494WBHIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
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
SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENEOld East Main Co.db876d34-1af9-4e0a-9e9a-32a8b00e94052026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 55910-877-21
ndc (product): 55910-877
ndc11 (package): 55910087721
spl id: 4c107ae8-fbfd-0833-e063-6394a90a88cb
spl set id: db876d34-1af9-4e0a-9e9a-32a8b00e9405

Reported adverse events (FAERS/openFDA)#

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