FDA.reportPublic FDA data

CHUDA

Manufacturer
Premier Ocher LLC
Effective date
2026-01-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:34:10

Label at a glance#

ProductCHUDA
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
Label structure7 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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: Sun Protection Measures. Limit time in the sun, especially ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3% Homosalate 15% Octinoxate 7.5%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

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 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

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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: Sun Protection Measures.
  • 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 in this container from excessive heat and direct sun

Inactive ingredients?

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Polymethylsilsesquioxane, Polysilicone-15, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Tribehenin, Olive (Olea europaea) Fruit Oil, Damask Rose (Rosa damascena) Flower Oil, Calcium Carbonate, Beeswax, Pollen, Propolis, Silica, Tocopheryl Acetate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Dehydroacetate, Dimethicone, Sodium Hyaluronate, Panthenol, Dimethiconol, Tetrasodium EDTA, Aminomethyl Propanol, Allantoin, Magnesium Aluminum Silicate, Sodium Ascorbate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71784-000-00CHUDA50 mL in 1 BOTTLECREAM505
71784-000-00CHUDA1 in 1 CARTONCREAM15

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
71784-00071784-000-00

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
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
POLYSILICONE-15F8DRP5BB29IACT
TRIBEHENIN8OC9U7TQZ0IACT
OLIVE OIL6UYK2W1W1EIACT
ROSA X DAMASCENA FLOWERING TOP21W82Q764GIACT
CALCIUM CARBONATEH0G9379FGKIACT
YELLOW WAX2ZA36H0S2VIACT
POLLEN3729L8MA2CIACT
PROPOLIS WAX6Y8XYV2NOFIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
DIMETHICONE92RU3N3Y1OIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PANTHENOLWV9CM0O67ZIACT
EDETATE SODIUMMP1J8420LUIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALLANTOIN344S277G0ZIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SODIUM ASCORBATES033EH8359IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

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
CHUDAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEPremier Ocher LLC1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f2026-01-20WarningsExact identifier
ndc (package): 71784-000-00
ndc (product): 71784-000
ndc11 (package): 71784000000
spl id: 48df8f0c-9184-979b-e063-6294a90af939
spl set id: 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f

Reported adverse events (FAERS/openFDA)#

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