FDA.reportPublic FDA data

Sunscreen

Manufacturer
Imperfect Foods
Effective date
2021-04-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:47

Label at a glance#

ProductSunscreen
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure12 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure reapply: use a water resistant sunscreen if swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15%

Octisalate 5%

Zinc Oxide 4%

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

On damaged or broken skin

Ask a doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash develops

When Using

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply liberally 15 minutes before sun exposure
  • reapply: use a water resistant sunscreen if swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Cetearyl Alcohol, Phenoxyethanol, C13-14 Isoparaffin, Caprylyl Glycol, Cyclotetrasiloxane, Lauroyl Lysine, Ethylhexylglycerin, Polyhydroxystearic Acid, Hexylene Glycol, Laureth-7, Allantoin, Dimethiconde/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Triethoxycaprylylsilane.

Questions or Comments?

OTC - QUESTIONS SECTION

1-833-906-2662 Monday - Friday 9AM-5PM MST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2803228032

SPF 15 Face Lotion NDC: 81757-001-04

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81757-001-042023-01-30C16284748780-1f386c64a-13bb-0266-e053-dadaa90a7c1abed990cf-1b60-0499-e053-2995a90aa355

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81757-001-04Sunscreen118 mL in 1 TUBELOTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81757-001SUNSCREEN (HOMOSALATE, OCTINOXATE, ZINC OXIDE) LOTION [IMPERFECT FOODS]3Legacy NDC, 1 package rows20210420_bed990cf-1b60-0499-e053-2995a90aa355.zip

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
81757-00181757-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
C13-14 ISOPARAFFINE4F12ROE70IACT
HOMOSALATEV06SV4M95SACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
OCTISALATE4X49Y0596WACTIB
OCTAMETHYLTETRASILOXANEYB15PH50RHIACT
LAURETH-7Z95S6G8201IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
EDETATE DISODIUM7FLD91C86KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALLANTOIN344S277G0ZIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PEG-100 STEARATEYD01N1999RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LAUROYL LYSINE113171Q70BIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT

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
c05595e4-b8dd-bda3-e053-2a95a90ac8c2bed990cf-1b60-0499-e053-2995a90aa3552021-04-19WarningsExact identifier
spl id: c05595e4-b8dd-bda3-e053-2a95a90ac8c2
spl set id: bed990cf-1b60-0499-e053-2995a90aa355

Reported adverse events (FAERS/openFDA)#

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