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Name:Arbonne Baby Care Sunscreen Spf 30
Manufacturer:Arbonne International, Llc
Category:Over-the-counter (OTC) Marketed Drugs


ARBONNE® ARBONNE BABY CARE®

ARBONNE BABY CARE  SUNSCREEN SPF 30 - octinoxate, octisalate, oxybenzone and zinc oxide cream 
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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ARBONNE®
ARBONNE BABY CARE®

Drug Facts

Active Ingredients Purpose
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 2.5% Sunscreen
Zinc Oxide 10% Sunscreen

Uses

  • helps prevent sunburn.
  • higher SPF gives more sunburn protection.
  • provides high protection against sunburn.
  • retains SPF after 40 minutes of perspiring.

Warnings

For external use only.

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally and evenly to all exposed areas 30 minutes before sun exposure.
  • reapply as needed or after towel drying, swimming or perspiring.
  • children under 6 months of age: ask a doctor.

Other Information

Store at 20°C-30°C (68°F-86°F)

Do not freeze.

Inactive Ingredients

Water, Neopentyl Glycol Diethylhexanoate, Polyglyceryl-4 Isostearate, Cyclopentasiloxane, Cetyl Dimethicone, Glycerin, Butylene Glycol, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Ceresin, Neopentyl Glycol Diisostearate, Magnesium Sulfate, Hydrogenated Castor Oil, Prunus Armeniaca (Apricot) Kernel Oil, Glycine Soja (Soybean) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Prunus Persica (Peach) Fruit Extract, Plantago Major Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Triethoxycaprylylsilane, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Panthenol, Hydrogenated Lecithin, Sodium Chloride, Caprylyl Glycol, Caprylhydroxamic Acid, Ricinus Communis (Castor) Seed Oil, Cedrus Atlantica Bark Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Dipteryx Odorata Seed Extract, Citrus Reticulata (Tangerine) Leaf Oil, Citrus Medica Limonum (Lemon) Peel Oil, Jasminum Officinale (Jasmine) Oil.

Questions or Comments?

1.800.272.6663

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

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

PRINCIPAL DISPLAY PANEL - 177 mL Carton

ARBONNE®

ABC

ARBONNE BABY CARE®

SUNSCREEN
SPF 30

6 fl. oz./177 mL

Principal Display Panel - 177 mL Carton

ARBONNE BABY CARE   SUNSCREEN SPF 30
octinoxate, octisalate, oxybenzone, and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-263
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 25 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
NEOPENTYL GLYCOL DIETHYLHEXANOATE  
POLYGLYCERYL-4 ISOSTEARATE  
CYCLOMETHICONE 5  
GLYCERIN  
BUTYLENE GLYCOL  
CYCLOMETHICONE 6  
HEXYL LAURATE  
CERESIN  
MAGNESIUM SULFATE, UNSPECIFIED  
HYDROGENATED CASTOR OIL  
APRICOT SEED OIL  
SOYBEAN OIL  
SAFFLOWER OIL  
PEACH  
PLANTAGO MAJOR  
CHAMOMILE  
OAT  
ALOE VERA LEAF  
SHEA BUTTER  
OCTYLTRIETHOXYSILANE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
VITAMIN A PALMITATE  
ASCORBYL PALMITATE  
PANTHENOL  
HYDROGENATED SOYBEAN LECITHIN  
SODIUM CHLORIDE  
CAPRYLYL GLYCOL  
CAPRYLHYDROXAMIC ACID  
CASTOR OIL  
CEDRUS ATLANTICA BARK OIL  
BERGAMOT OIL  
ORANGE OIL  
CITRUS RETICULATA LEAF OIL  
LEMON OIL  
JASMINUM OFFICINALE FLOWER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42508-263-25 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 177 mL in 1 BOTTLE This package is contained within the CARTON (42508-263-25)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/01/2010

Labeler - Arbonne International, LLC (021541164)

Revised: 11/2010 Arbonne International, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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