ABC ARBONNE BABY CARE SAMPLE SET- dimethicone and zinc oxide kit

ABC Arbonne Baby Care Sample Set by

Drug Labeling and Warnings

ABC Arbonne Baby Care Sample Set by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ABC ARBONNE BABY CARE SAMPLE SET 
dimethicone and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-196

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-196-10	1 in 1 CARTON	04/15/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	3 mL
Part 2	1 TUBE	3 mL
Part 3	1 TUBE	3 mL
Part 4	1 TUBE	3 mL

Part 1 of 4

ABC ARBONNE BABY CARE   SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.4 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		3 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/15/2016

Part 2 of 4

ABC ARBONNE BABY CARE   DIAPER RASH
dimethicone and zinc oxide cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 mg  in 3 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		3 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	04/15/2016

Part 3 of 4

ABC ARBONNE BABY CARE   HAIR AND BODY WASH
baby shampoos gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	ISOPROPYL ALCOHOL (UNII: ND2M416302)
INGR	LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	SODIUM ACETATE (UNII: 4550K0SC9B)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
INGR	SODIUM GLUCONATE (UNII: R6Q3791S76)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
INGR	P-ANISALDEHYDE (UNII: 9PA5V6656V)
INGR	LINALYL ACETATE (UNII: 5K47SSQ51G)
INGR	DECANAL (UNII: 31Z90Q7KQJ)
INGR	VANILLIN (UNII: CHI530446X)
INGR	AMBRETTE SEED OIL (UNII: YC79BB3F4Y)
INGR	SANDALWOOD OIL (UNII: X7X01WMQ5F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		04/15/2016

Part 4 of 4

ABC ARBONNE BABY CARE   BODY
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	GINGER (UNII: C5529G5JPQ)
INGR	LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
INGR	P-ANISALDEHYDE (UNII: 9PA5V6656V)
INGR	LINALYL ACETATE (UNII: 5K47SSQ51G)
INGR	DECANAL (UNII: 31Z90Q7KQJ)
INGR	VANILLIN (UNII: CHI530446X)
INGR	AMBRETTE SEED OIL (UNII: YC79BB3F4Y)
INGR	SANDALWOOD OIL (UNII: X7X01WMQ5F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		04/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/15/2016

Labeler - Arbonne International, LLC (021541164)