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ABC Arbonne Baby Care Sample Set

Medically reviewed on Sep 13, 2018

Dosage form: kit
Ingredients: ZINC OXIDE 14.4mg in 3mL; DIMETHICONE 1mg in 3mL, ZINC OXIDE 12mg in 3mL;
Labeler: Arbonne International, LLC
NDC Code: 42508-196

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.

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

Established Pharmacological Class
SubstancePharmacological Class
ABC Arbonne Baby Care Hair and Body WashBABY SHAMPOOS
ABC Arbonne Baby Care BodyLOTIONS, OILS, POWDERS, AND CREAMS
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 Description
1NDC:42508-196-101 KIT in 1 CARTON
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE14.4 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALKYL (C12-15) BENZOATE 
CALENDULA OFFICINALIS FLOWER 
MEDIUM-CHAIN TRIGLYCERIDES 
CETYL ALCOHOL 
CETYL DIMETHICONE 45 
CHAMOMILE 
CHLORPHENESIN 
COCO-CAPRYLATE 
CARNAUBA WAX 
DICAPRYLYL CARBONATE 
CANDELILLA WAX 
GLYCERIN 
MAGNESIUM SULFATE, UNSPECIFIED FORM 
PHENOXYETHANOL 
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE 
POLYGLYCERYL-4 ISOSTEARATE 
SILICA DIMETHYL SILYLATE 
SODIUM CHLORIDE 
STEARIC ACID 
STARCH, TAPIOCA 
.ALPHA.-TOCOPHEROL ACETATE 
TRIETHOXYCAPRYLYLSILANE 
WATER 
Packaging
#Item CodePackage Description
13 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/15/2016
Part 2 of 4
ABC ARBONNE BABY CARE   DIAPER RASH
dimethicone and zinc oxide cream
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1 mg  in 3 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE12 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
CALENDULA OFFICINALIS FLOWER 
CHAMOMILE 
CHLORPHENESIN 
CARNAUBA WAX 
DICAPRYLYL CARBONATE 
DIISOPROPYL SEBACATE 
GLYCERIN 
GLYCERYL BEHENATE/EICOSADIOATE 
MAGNESIUM SULFATE, UNSPECIFIED FORM 
PHENOXYETHANOL 
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE 
POLYGLYCERYL-4 ISOSTEARATE 
SODIUM CHLORIDE 
SODIUM STEARATE 
TOCOPHEROL 
WATER 
Packaging
#Item CodePackage Description
13 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/15/2016
Part 3 of 4
ABC ARBONNE BABY CARE   HAIR AND BODY WASH
gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
ASCORBYL PALMITATE 
CALENDULA OFFICINALIS FLOWER 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
CHAMOMILE 
CHLORPHENESIN 
CITRIC ACID MONOHYDRATE 
COCAMIDOPROPYL BETAINE 
DISODIUM COCOYL GLUTAMATE 
GLYCERIN 
SUNFLOWER OIL 
HYDROGENATED SOYBEAN LECITHIN 
ISOPROPYL ALCOHOL 
LAURYL GLUCOSIDE 
PHENOXYETHANOL 
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) 
POLYSORBATE 20 
POTASSIUM SORBATE 
SALICYLIC ACID 
SODIUM ACETATE 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM COCOYL GLUTAMATE 
SODIUM GLUCONATE 
SODIUM LAUROYL SARCOSINATE 
SODIUM PYRROLIDONE CARBOXYLATE 
SORBIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
LEVANT COTTONSEED OIL 
P-ANISALDEHYDE 
LINALYL ACETATE 
DECANAL 
VANILLIN 
AMBRETTE SEED OIL 
SANDALWOOD OIL 
Packaging
#Item CodePackage Description
13 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/15/2016
Part 4 of 4
ABC ARBONNE BABY CARE   BODY
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
ALLANTOIN 
ALOE VERA LEAF 
AMINOMETHYLPROPANOL 
LEVOMENOL 
SHEA BUTTER 
CALENDULA OFFICINALIS FLOWER 
CAPRYLHYDROXAMIC ACID 
MEDIUM-CHAIN TRIGLYCERIDES 
CAPRYLYL GLYCOL 
CARBOXYPOLYMETHYLENE 
SAFFLOWER OIL 
CHAMOMILE 
CHLORPHENESIN 
DIMETHICONE 
GLYCERIN 
GLYCERYL STEARATE CITRATE 
SUNFLOWER OIL 
OLIVE OIL 
SQUALANE 
STEARIC ACID 
TOCOPHEROL 
GINGER 
LEVANT COTTONSEED OIL 
P-ANISALDEHYDE 
LINALYL ACETATE 
DECANAL 
VANILLIN 
AMBRETTE SEED OIL 
SANDALWOOD OIL 
Packaging
#Item CodePackage Description
13 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC04/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/2016
Labeler - Arbonne International, LLC (021541164)

 
Arbonne International, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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