FDA.reportPublic FDA data

Sunscreen

Manufacturer
OLD EAST MAIN CO. | Vi-Jon, LLC
Effective date
2022-03-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:49:29

Label at a glance#

ProductSunscreen
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, OCTOCRYLENE
Label structure16 sections

Indications and uses

helps prevent sunburn if used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Directions ■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel dryin g ■ 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 incl...

Label contents#

Full prescribing information#

claims

SPL UNCLASSIFIED SECTION

CLEAR ZINC SUNSCREEN

BROAD SPECTRUM SPF 50

Dermatologist-Tested • UVA/UVB Protection
Goes on Clear • With Aloe and Vitamin E

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 skin 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

OTC - STOP USE SECTION

if 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

Directions
■ apply liberally 15 minutes before sun exposure
■ 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 from excessive heat and direct sun

inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA

claims

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces 

disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 70

DSP-TN-15000  DSP-MO-34 SDS-TN-15012

100%

Satisfaction

Guaranteed!

(888)309-9030

Adversation reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO

SELECTION SUN

CLEAR ZINC SUNSCREEN

BROAD SPECTRUM SPF 50

  • Water-Resistant (80 minutes)
  • For face, nose or ears
  • Paraben Free

SPF 50

NET WT 1 OZ (28.3 g)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-72655910-726-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPANEDIOL5965N8W85TIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%)VP5LS3541FIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
triethoxycaprylylsilaneLDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
EDETATE SODIUMMP1J8420LUIACT

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
24240f38-63fd-d950-e063-6394a90a7e7b81d528e5-e03b-47c3-a1c7-d0a92586da5b2024-10-10Warnings, Adverse reactionsExact identifier
spl set id: 81d528e5-e03b-47c3-a1c7-d0a92586da5b

Reported adverse events (FAERS/openFDA)#

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