FDA.reportPublic FDA data

GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen

Manufacturer
Arbonne International, LLC | Levlad, LLC
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:37:06

Label at a glance#

ProductGroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen
Active ingredientZINC OXIDE
Label structure11 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

For sunscreen use: apply liberally and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor Sun Protection Measures. 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 ...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 4.95%

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

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures.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:
    • limit time in the sun, especially from 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, saccharide isomerate, steareth-21, squalane, ammonium acryloyldimethyltaurate/VP copolymer, caprylic/capric triglyceride, dimethicone, steareth-2, aloe barbadensis leaf juice, hydrolyzed ceratonia siliqua seed extract, laminaria digitata extract, chamomilla recutita (matricaria) flower extract, sophora japonica flower extract, tripleurospermum maritimum extract, malachite extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, menthol, adenosine, sodium hyaluronate, polyglyceryl-3 laurate, sorbitan oleate, sorbitan isostearate, myristic acid, palmitic acid, stearic acid, triethoxycaprylylsilane, polysorbate 60, propanediol, trisodium ethylenediamine disuccinate, sodium citrate, citric acid, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium benzoate, potassium sorbate, sorbic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-272-6663

Monday–Friday 6 a.m.–6 p.m. PST

SPL UNCLASSIFIED SECTION

Distributed by Arbonne International, LLC • Greenwood, IN 46143 USA

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GroomWell

100% VEGAN – CRUELTY-FREE

WEIGHTLESS CREAM
WITH MINERAL BROAD SPECTRUM
SPF 15 SUNSCREEN

All Skin Types

Net wt. 1.7 oz. / 50 g

GroomWell Weightless Cream SPF 15 LabelGroomWell Weightless Cream SPF 15 Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42508-827-23GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen50 g in 1 JARCREAM504
42508-827-23GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42508-827GROOMWELL WEIGHTLESS WITH MINERAL BROAD SPECTRUM SPF 15 SUNSCREEN (ZINC OXIDE) CREAM [ARBONNE INTERNATIONAL, LLC]4Legacy NDC, 2 package rows20241115_3c0e3a90-1cfb-4a6a-b36b-931c839fec25.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42508-82742508-827-23

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
STEARETH-2153J3F32P58IACT
SQUALANEGW89575KF9IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
STEARETH-2V56DFE46J5IACT
ALOE VERA LEAFZY81Z83H0XIACT
LAMINARIA DIGITATA15E7C67EE8IACT
CHAMOMILEFGL3685T2XIACT
STYPHNOLOBIUM JAPONICUM FLOWER644C3CSB6EIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
ADENOSINEK72T3FS567IACT
HYALURONATE SODIUMYSE9PPT4THIACT
POLYGLYCERYL-3 LAURATEY9ZSR39D0EIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
MYRISTIC ACID0I3V7S25AWIACT
PALMITIC ACID2V16EO95H1IACT
STEARIC ACID4ELV7Z65APIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPANEDIOL5965N8W85TIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
26ba2cd5-d79d-61f8-e063-6394a90affe33c0e3a90-1cfb-4a6a-b36b-931c839fec252024-11-12WarningsExact identifier
spl id: 26ba2cd5-d79d-61f8-e063-6394a90affe3
spl set id: 3c0e3a90-1cfb-4a6a-b36b-931c839fec25

Reported adverse events (FAERS/openFDA)#

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