FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:48:35

Label at a glance#

ProductAvobenzone, Homosalate, Octisalate
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure14 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 liberaly 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 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%

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberaly 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy 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, butyloctyl salicylate, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, caprylyl methicone, aluminum starch octenylsuccinate, cetyl dimethicone, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, fragrance, glycerin, disodium EDTA, ethylhexyl stearate, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate

Claims

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Neutrogena ®Ultra Sheer ®Dry-Touch Sunscreen Broad Spectrum SPF 70.

May stain or damage some fabrics or surfaces.

Pat. Pend.

Adverse Reactions

ADVERSE REACTIONS SECTION

100% Satisfaction Guaranteed!

(888) 309-9030

DISTRIBUTED BY

OLD EAST MIN CO.

100 MISSION RIDGE,

GOODLETTSVILLE, TN 37072

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO SELECTION ®

SUN

SHEER TOUCH

SUNSCREEN LOTION

BROAD SPECTRUM SPF 70

COMPARE TO NEUTROGENA ®ULTRA SHEER ®SUNSCREEN Broad Spectrum SPF 70*

  • Water-Resistant (80 Minutes)
  • Lightweight, clean skin feel

SPF 70

Dermatologist-Tested 

UVA/UVB Sunscreen

3 FL OZ (88 mL)

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0021412TAmm01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-935-21Avobenzone, Homosalate, Octisalate88 mL in 1 TUBELOTION884

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75712-93575712-935-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
BENZYL ALCOHOLLKG8494WBHIACT
YELLOW WAX2ZA36H0S2VIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CETYL DIMETHICONE 1505L694Y0T22IACT
DOCOSANOL9G1OE216XYIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENESINI670DAL4SZIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TRIDECETH-63T5PCR2H0CIACT
PENTYLENE GLYCOL50C1307PZGIACT
BENZYL BENZOATEN863NB338GIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
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.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 75712-935-21
ndc (product): 75712-935
ndc11 (package): 75712093521
spl id: 4c10ea4b-f643-07f7-e063-6294a90a41a3
spl set id: 8f4a6a31-2fae-42fe-924f-10237c59e791

Reported adverse events (FAERS/openFDA)#

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