FDA.reportPublic FDA data

Cloud Brush On Sunscreen SPF 50

Manufacturer
FUTURE 8 LLC | Pure Source, LLC
Effective date
2025-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:38:50

Label at a glance#

ProductCloud Brush On Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure8 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 liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor.  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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and oth...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25.00%

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 or irritation develops and lasts.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions.

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor. 
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF 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.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Coco-Caprylate, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Lens Esculenta (Lentil) Fruit Extract, Polyhydroxystearic Acid, Propanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sodium Stearoyl Glutamate, Squalane, Stearic Acid, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

(212) 913-0169

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130601527993648GTIN-13: 0601527993648
EAN-13: 0601527993648
GTIN-12: 601527993648
UPC-A: 601527993648
GTIN storage (14 digits): 00601527993648		Label.jpg
Data codeQR Codewww.cloud.lol/ingredientsLabel.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85678-897-00Cloud Brush On Sunscreen SPF 501 in 1 BOXCREAM11
85678-897-00Cloud Brush On Sunscreen SPF 5050 mL in 1 JARCREAM501

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
85678-89785678-897-00

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
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
COCO-CAPRYLATE4828G836N6IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE230OU9XXE4IACT
LENTIL6O38V6B52OIACT
PROPANEDIOL5965N8W85TIACT
APPLEB423VGH5S9IACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SQUALANEGW89575KF9IACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Cloud Brush On Sunscreen SPF 50ZINC OXIDEFUTURE 8 LLC8b1eaf6c-9cd8-4c5e-beac-b8539c332ae32025-10-13WarningsExact identifier
ndc (package): 85678-897-00
ndc (product): 85678-897
ndc11 (package): 85678089700
spl id: 4109ac77-95e6-15b5-e063-6294a90aa843
spl set id: 8b1eaf6c-9cd8-4c5e-beac-b8539c332ae3

Reported adverse events (FAERS/openFDA)#

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