ABC ARBONNE BABY CARE KIT- dimethicone, zinc oxide kit

ABC Arbonne Baby Care by

Drug Labeling and Warnings

ABC Arbonne Baby Care 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

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
• 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

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

Questions or comments?

1.800.272.6663
Monday–Friday 6 a.m.–6 p.m. PST

SPL UNCLASSIFIED SECTION

DIAPER RASH CREAM

Drug Facts

Active ingredients

Dimethicone 1%
Zinc Oxide 12%

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

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

Questions or comments?

1.800.272.6663
Monday–Friday 6 a.m.–6 p.m. PST

SPL UNCLASSIFIED SECTION

Distributed by
Arbonne International, LLC, 9400 Jeronimo Road, Irvine, CA 92618 U.S.A.

PRINCIPAL DISPLAY PANEL - Kit Carton

ARBONNE®

A
B
C

ARBONNE BABY CARE®

HAIR & BODY WASH
8 fl. oz./236 mL

BODY LOTION
8 fl. oz./236 mL

DIAPER RASH CREAM
Net wt. 5 oz./141 g

SUNSCREEN BROAD SPECTRUM SPF 30
WATER-RESISTANT (40 MINUTES)
6 fl. oz./177 mL

INGREDIENTS AND APPEARANCE

ABC ARBONNE BABY CARE  KIT
dimethicone, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-538

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-538-04	1 in 1 CARTON	09/20/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	177 mL
Part 2	1 TUBE	141 g

Part 1 of 2

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	144 mg  in 1 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		177 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	09/20/2014

Part 2 of 2

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 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 g

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		141 g 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	09/20/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/20/2014

Labeler - Arbonne International, LLC (021541164)