GROOMWELL WEIGHTLESS WITH MINERAL BROAD SPECTRUM SPF 15 SUNSCREEN- zinc oxide cream

GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC, Levlad, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 4.95%

Purpose

Sunscreen

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

Warnings

For external use only

Do not useon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs.

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

Directions

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

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

Inactive ingredients

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?

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

GroomWell

100% VEGAN – CRUELTY-FREE

WEIGHTLESS CREAM
WITH MINERAL BROAD SPECTRUM
SPF 15 SUNSCREEN

All Skin Types

Net wt. 1.7 oz. / 50 g

INGREDIENTS AND APPEARANCE

GROOMWELL WEIGHTLESS WITH MINERAL BROAD SPECTRUM SPF 15 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-827
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
STEARETH-21 (UNII: 53J3F32P58)
SQUALANE (UNII: GW89575KF9)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-2 (UNII: V56DFE46J5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
CHAMOMILE (UNII: FGL3685T2X)
STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
MYRISTIC ACID (UNII: 0I3V7S25AW)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPANEDIOL (UNII: 5965N8W85T)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-827-23	1 in 1 CARTON	04/27/2021	07/26/2026
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/27/2021	07/26/2026

Labeler - Arbonne International, LLC (961643454)

Registrant - Levlad, LLC (076245109)

Establishment
Name	Address	ID/FEI	Business Operations
Levlad, LLC		076245109	manufacture(42508-827) , label(42508-827) , pack(42508-827) , analysis(42508-827)