FDA.reportPublic FDA data

Sweet Pea Sheer Shield SPF45

Manufacturer
The Hain Celestial Group, Inc. | The Hain Celestial Group, Inc
Effective date
2022-12-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:52:23

Label at a glance#

ProductFacial Sheer Shield SPF45
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone - 3.0%

Homosalate – 10.0%

Octocrylene – 10.0%

Octyl Salicylate – 5.0%

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

Water (Aqua), Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Aloe Barbadensis Leaf Juice(1), Calendula Officinalis Flower Extract(1), Camellia Sinensis Leaf Extract(1), Chamomilla Recutita (Matricaria) Flower Extract(1), Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract(1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol(1), Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organic Ingredient

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions) decreases risk of skin cancer and early signs of agin caused by the sun.

RECENT MAJOR CHANGES SECTION

Indications and Usage update

Inactive ingredients update

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AL00503 LabelAL00503 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-1969-12024-01-30C16284748780-1ba0f9c33-5dea-a910-e053-dadaa90a0b85AL00969 Sweet Pea Sheer Shield SPF 45
61995-0969-32021-02-05C16284748780-1ba0f9c33-5dea-a910-e053-dadaa90a0b85AL00969 Sweet Pea Sheer Shield SPF 45
61995-0969-32021-01-29C16284748780-1ba0f9c33-5dea-a910-e053-dadaa90a0b85AL00969 Sweet Pea Sheer Shield SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1969-1Facial Sheer Shield SPF4556 g in 1 TUBELOTION568

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1969FACIAL SHEER SHIELD SPF45 (AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCRYLENE 10.0%) LOTION [THE HAIN CELESTIAL GROUP, INC.]8Legacy NDC, 1 package rows20221203_99741e3c-cce2-407b-e053-2995a90ae6d7.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-196961995-1969-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL STEARATE SEFCZ5MH785IIACT
ORANGE OILAKN3KSD11BIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GINKGO BILOBA LEAF OILY5967KO1JHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETEARYL OLIVATE58B69Q84JOIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLYSORBATE 60CAL22UVI4MIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SORBITAN OLIVATEMDL271E3GRIACT
ALCOHOL3K9958V90MIACT
CHAMOMILEFGL3685T2XIACT
LAVANDULA ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM CHLORIDE451W47IQ8XIACT
AVOBENZONEG63QQF2NOXACTIB
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HOMOSALATEV06SV4M95SACTIB
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
PANAX GINSENG ROOT OILP9T4K47OM0IACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
OCTISALATE4X49Y0596WACTIB
XANTHAN GUMTTV12P4NEEIACT
BENZYL ALCOHOLLKG8494WBHIACT
DIMETHICONE92RU3N3Y1OIACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT

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
eed126a7-505a-676f-e053-2a95a90ae4ef99741e3c-cce2-407b-e053-2995a90ae6d72022-12-01WarningsExact identifier
spl id: eed126a7-505a-676f-e053-2a95a90ae4ef
spl set id: 99741e3c-cce2-407b-e053-2995a90ae6d7

Reported adverse events (FAERS/openFDA)#

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