PELLE WELLNESS SPF 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN

Manufacturer
Pelle Wellness LLC
Effective date
2023-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:00

Label at a glance#

ProductPELLE WELLNESS SPF 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed Decreases the risk of skin cancer and early signs of aging caused by the sun

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure Reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Use a water-resistant sunscreen if swimming. Children after 6 months: Ask a doctor

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 6.0%

TITANIUM DIOXIDE 2.5%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed
  • Decreases the risk of skin cancer and early signs of aging caused by the sun

WARNINGS

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • 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 doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Use a water-resistant sunscreen if swimming.

Children after 6 months: Ask a doctor

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cyclohexasiloxane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Sucrose Cocoate, Citric Acid, Glyceryl Isostearate, Polyhydroxystearic Acid, Sodium Citrate, Sodium PCA, Caprylyl Methicone, Alumina, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Chlorphenesin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone,
Allantoin, Xanthan Gum, Glyceryl Undecylenate, Glycerin, Magnesium Ascorbyl Phosphate, Panthenol, Phytic Acid, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Phenoxyethanol, Sodium Hyaluronate

Questions or Comments?

OTC - QUESTIONS SECTION

call 626-877-8505

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lbllbl

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83625-102-322025-01-30C16284748780-12cef2736-a748-d83d-e063-dadaa90ab31fPelle Wellness (as PLD) - SPF 30 Face & Body Broad Spectrum Mineral Sunscreen (83625-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83625-102-32PELLE WELLNESS SPF 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN1000 mL in 1 BOTTLECREAM10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83625-102PELLE WELLNESS SPF 30 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PELLE WELLNESS LLC]11 package rows20230828_03dd6ffb-d67f-a483-e063-6294a90a84e1.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83625-10283625-102-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

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
03dd6f8e-5070-dffd-e063-6294a90a81cc03dd6ffb-d67f-a483-e063-6294a90a84e12023-08-26WarningsExact identifier
spl id: 03dd6f8e-5070-dffd-e063-6294a90a81cc
spl set id: 03dd6ffb-d67f-a483-e063-6294a90a84e1

Reported adverse events (FAERS/openFDA)#

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