FDA.reportPublic FDA data

AV453902 Avalon Organics Intense Defense Sheer Moisture SPF10

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:51

Label at a glance#

ProductAV453902 Avalon Organics Intense Defense Sheer Moisture SPF10
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 3.6%

Titanium Dioxide 2.8%

DOSAGE & ADMINISTRATION SECTION

Apply liberally after cleansing and toning and 15 minutes before sun exposure.

OTC - PURPOSE SECTION

Sunscreen

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 skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice(1),Coconut Alkanes, Argania Spinosa Kernel Oil (1), Caprylic Capric Triglyceride, Glycerin, Polyglyceryl-3 Ricinoleate, Limonene, Sesamum Indicum (Sesame) Seed Oil, Polyglyceryl-2 Sesquioleate, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Rosa Canina (Rosehip) Fruit Oil (1), Camellia Sinensis Leaf Extract (1), Citrus Limon (Lemon) Peel Extract (1), Polyhydroxystearic Acid,Tocopheryl Acetate, Ascorbyl Glucoside, Alumina, Water,Calcium Ascorbate, Calcium Carbonate, Coco-Caprylate/Caprate, Sodium Chloride, Stearic Acid, Alcohol (1), Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Linalool.

(1) Certified Organicf Ingredient

INDICATIONS & USAGE SECTION

Helps prevents sunburns.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton labelbottle labelbottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-1392-22023-01-30C16284748780-1ba0f9c33-5bbf-a910-e053-dadaa90a0b85AV453902 Avalon Organics Intense Defense Sheer Moisture SPF10
61995-1392-22021-02-05C16284748780-1ba0f9c33-5bbf-a910-e053-dadaa90a0b85AV453902 Avalon Organics Intense Defense Sheer Moisture SPF10
61995-1392-22021-01-29C16284748780-1ba0f9c33-5bbf-a910-e053-dadaa90a0b85AV453902 Avalon Organics Intense Defense Sheer Moisture SPF10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1392-2AV453902 Avalon Organics Intense Defense Sheer Moisture SPF101 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1392AV453902 AVALON ORGANICS INTENSE DEFENSE SHEER MOISTURE SPF10 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [THE HAIN CELESTIAL GROUP, INC.]3Legacy NDC, 1 package rows20210207_47814e58-90db-379b-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-139261995-1392-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEMON OILI9GRO824LLIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LEMON24RS0A988OIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
CALCIUM CARBONATEH0G9379FGKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRALT7EU0O9VPPIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BERGAMOT OIL39W1PKE3JIIACT
SODIUM BENZOATEOJ245FE5EUIACT
ORANGE OILAKN3KSD11BIACT
CALCIUM ASCORBATE183E4W213WIACT
ALCOHOL3K9958V90MIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT ALKANES1E5KJY107TIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
ALUMINUM OXIDELMI26O6933IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARIC ACID4ELV7Z65APIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
LIMONENE, (+)-GFD7C86Q1WIACT
SESAME OILQX10HYY4QVIACT
POLYGLYCERYL-2 SESQUIISOSTEARATELA272Q68GQIACT
ARGAN OIL4V59G5UW9XIACT

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
baa08f4d-1588-67a0-e053-2a95a90a96da47814e58-90db-379b-e054-00144ff88e882021-02-05WarningsExact identifier
spl id: baa08f4d-1588-67a0-e053-2a95a90a96da
spl set id: 47814e58-90db-379b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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