FDA.reportPublic FDA data

SUN SHIELD SUNSCREEN

Manufacturer
Winning Solutions
Effective date
2023-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:31

Label at a glance#

ProductSUN SHIELD SUNSCREEN SPF 30
Active ingredientHOMOSALATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure8 sections

Indications and uses

HELPS PREVENT SUNBURN

Dosage and administration

apply generously 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours under 6 months of age: ask a doctor 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 2.0%

HOMOSALATE 10.0%

OCTISALATE 5.0%

OCTOCRYLENE 5.0%

OXYBENZONE 5.0%

Purpose

OTC - PURPOSE SECTION

SUNSCREEN

Uses

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN

Warnings

WARNINGS SECTION

For external use only.

Do not use

  • on damaged or broken skin.

When using this product

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

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously 15 minutes before sun exposure.

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • under 6 months of age: ask a doctor
  • 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, stearic acid, cetyl alcohol, aloe barbadensis leaf, c12-15 alkyl benzoate, dea-cetyl phosphate, vp/eicosene copolymer, phenoxyethanol, dimethicone, triethanolamine, carbomer, titanium dioxide, glycereth-2 cocoate, tocopheryl acetate, retinyl palmitate, iodopropynyl butylcarbamate, chamomilla recutitita (matricaria) flower extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Sun Shield SPF 30_30mL01b LBL_Sun Shield SPF 30_30mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66391-3001-12025-01-30C16284748780-12cef2736-8efc-d83d-e063-dadaa90ab31fWinning Solutions (as PLD) - Sun Shield Sunscreen SPF 30 (66391-3001)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66391-3001-1SUN SHIELD SUNSCREENSPF 3030 mL in 1 TUBELOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66391-3001SUN SHIELD SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WINNING SOLUTIONS]21 package rows20230127_f332a0b6-639b-3f46-e053-2995a90a7966.zip

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
66391-300166391-3001-1

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
STEARIC ACID4ELV7Z65APIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
OXYBENZONE95OOS7VE0YACTIB
GLYCERINPDC6A3C0OXIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
ALOE VERA LEAFZY81Z83H0XIACT
DIETHANOLAMINE CETYL PHOSPHATE4UG0316V9SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHICONE92RU3N3Y1OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETYL ALCOHOL936JST6JCNIACT

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
f33361a7-e049-4681-e053-2a95a90ab909f332a0b6-639b-3f46-e053-2995a90a79662023-01-26WarningsExact identifier
spl id: f33361a7-e049-4681-e053-2a95a90ab909
spl set id: f332a0b6-639b-3f46-e053-2995a90a7966

Reported adverse events (FAERS/openFDA)#

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