ABC ARBONNE BABY CARE SAMPLE SET- dimethicone and zinc oxide 
Arbonne International, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ABC Arbonne Baby Care® Sample Set
Kit

Sunscreen Broad Spectrum SPF 30
Water-Resistant (40 minutes)

Drug Facts

Active ingredients

Zinc oxide 14.4%

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 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 rash occurs

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

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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
    • children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

water, c12-15 alkyl benzoate, caprylic/capric triglyceride, coco-caprylate, polyglyceryl-2 dipolyhydroxystearate, dicaprylyl carbonate, polyglyceryl-4 isostearate, cetyl dimethicone, glycerin, copernicia cerifera (carnauba) wax, cetyl alcohol, euphorbia cerifera (candelilla) wax, tapioca starch, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, triethoxycaprylylsilane, tocopheryl acetate, magnesium sulfate, sodium chloride, silica dimethyl silylate, stearic acid, chlorphenesin, phenoxyethanol.

Questions or comments?

1.800.272.6663

Monday–Friday 6 a.m.–6 p.m. Pacific time

Diaper Rash Cream

Drug Facts

Active ingredients

Dimethicone 1%
Zinc oxide 12.0%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

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

Directions

  • change wet or soiled diapers promptly, cleanse the diaper area and dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

  • Store between 20°C–25°C/68°F–77°F

Inactive ingredients

water, dicaprylyl carbonate, diisopropyl sebacate, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-4 isostearate, dipentaerythrityl tri-polyhydroxystearate, glycerin, glyceryl behenate/eicosadioate, helianthus annuus (sunflower) seed oil unsaponifiables, arnica montana flower extract, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, copernicia cerifera (carnauba) wax, tocopherol, magnesium sulfate, sodium chloride, sodium stearate, chlorphenesin, phenoxyethanol.

Questions or comments?

1.800.272.6663

Monday–Friday 6 a.m.–6 p.m. Pacific time

Distributed by
Arbonne International, LLC
9400 Jeronimo Road
Irvine, CA 92618 USA

PRINCIPAL DISPLAY PANEL - Kit Carton

ARBONNE®
pure safe beneficial

ABC
ARBONNE BABY CARE®

Dermatologist Tested

4 x 0.1 fl. oz./3 mL

PRINCIPAL DISPLAY PANEL - Kit Carton
ABC ARBONNE BABY CARE SAMPLE SET 
dimethicone and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-196
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42508-196-101 in 1 CARTON04/15/201601/08/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 3 mL
Part 21 TUBE 3 mL
Part 31 TUBE 3 mL
Part 41 TUBE 3 mL
Part 1 of 4
ABC ARBONNE BABY CARE   SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.4 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
CHAMOMILE (UNII: FGL3685T2X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CANDELILLA WAX (UNII: WL0328HX19)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/15/201601/08/2022
Part 2 of 4
ABC ARBONNE BABY CARE   DIAPER RASH
dimethicone and zinc oxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mg  in 3 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/15/201601/08/2022
Part 3 of 4
ABC ARBONNE BABY CARE   HAIR AND BODY WASH
baby shampoos gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRDISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRISOPROPYL ALCOHOL (UNII: ND2M416302)  
INGRLAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRSODIUM ACETATE (UNII: 4550K0SC9B)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
INGRSODIUM GLUCONATE (UNII: R6Q3791S76)  
INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRSORBIC ACID (UNII: X045WJ989B)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRWATER (UNII: 059QF0KO0R)  
INGRLEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
INGRP-ANISALDEHYDE (UNII: 9PA5V6656V)  
INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
INGRDECANAL (UNII: 31Z90Q7KQJ)  
INGRVANILLIN (UNII: CHI530446X)  
INGRAMBRETTE SEED OIL (UNII: YC79BB3F4Y)  
INGRSANDALWOOD OIL (UNII: X7X01WMQ5F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/15/201601/08/2022
Part 4 of 4
ABC ARBONNE BABY CARE   BODY
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRAMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRGLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRGINGER (UNII: C5529G5JPQ)  
INGRLEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
INGRP-ANISALDEHYDE (UNII: 9PA5V6656V)  
INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
INGRDECANAL (UNII: 31Z90Q7KQJ)  
INGRVANILLIN (UNII: CHI530446X)  
INGRAMBRETTE SEED OIL (UNII: YC79BB3F4Y)  
INGRSANDALWOOD OIL (UNII: X7X01WMQ5F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/15/201601/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/201601/08/2022
Labeler - Arbonne International, LLC (021541164)

Revised: 11/2022
 
Arbonne International, LLC