FDA.reportPublic FDA data

Sunscreen

Manufacturer
Imperfect Foods
Effective date
2021-04-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:39:59

Label at a glance#

ProductSunscreen
Active ingredientZINC OXIDE
Label structure12 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Spray on hands and apply to face use in well-ventilated area do not inhale children under 6 months: 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 sunscre...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14%

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 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.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 degrees F.

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: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Spray on hands and apply to face
  • use in well-ventilated area
  • do not inhale
  • children under 6 months: 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 Broad Spectrum value of 15 or higher along with other sun protection measures including:

  • limit time in the sun, especially from 10a.m. - 2 p.m.
  • wear long sleeved shirts, pants, hats and sunglasses

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid , Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cellulose Gum, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Helianthus Annuus (Sunflower) Oil, Jojoba Esters, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Tocopherol, Water.

Questions or Comments?

OTC - QUESTIONS SECTION

1-833-909-2662 Monday - Friday 9am-5pm MST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2803328033SPF 30 Sunscreen Spray NDC: 81757-002-06

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81757-002-062023-01-30C16284748780-1f386c649-d741-0266-e053-dadaa90a7c1abfdba9a2-51dd-5c33-e053-2a95a90af654

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81757-002-06Sunscreen171 g in 1 CANSPRAY1715

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81757-002SUNSCREEN (ZINC OXIDE) SPRAY [IMPERFECT FOODS]5Legacy NDC, 1 package rows20210427_bfdba9a2-51dd-5c33-e053-2a95a90af654.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81757-00281757-002-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENTONITEA3N5ZCN45CIACT
LEVOMENOL24WE03BX2TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SAFFLOWER OIL65UEH262ISIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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
c0ec5df0-183a-5a81-e053-2a95a90a98b4bfdba9a2-51dd-5c33-e053-2a95a90af6542021-04-26WarningsExact identifier
spl id: c0ec5df0-183a-5a81-e053-2a95a90a98b4
spl set id: bfdba9a2-51dd-5c33-e053-2a95a90af654

Reported adverse events (FAERS/openFDA)#

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