Andalou BB Untinted with SPF-30

Dosage form: lotion
Ingredients: Zinc Oxide 20g in 100mL
Labeler: Andalou naturals
NDC Code: 55560-0101

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.

Andalou BB Untinted with SPF-30

Drug Facts

Active Ingredient

Zinc Oxide 20%

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 or irritation develops and lasts.

Directions
  • Daily, alone or under make-up.
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply at least every 2 hours.
  • Use water resistant sunscreen if swimming or sweating.
  • 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis Juice, Simmondsia Chinensis (Jojoba) and Helianthus Annuus (Sunflower) Oils1, Sorbitan Stearate, Glyceryl Stearate, Fruit Stem Cell and BioActive 8 Berry Complex1, Caprylic/Capric Triglycerides, Hyaluronic Acid, Salvia Officinalis (Sage), Serenoa Rapens (Saw Palmetto) and Salix Alba (Willow Bark) Extracts1, Punica Granatum (Pomegranate) Oil1, Magnesium Ascorbyl Phosphate (Vitamin C), Algae Extract, Zinc Gluconate, Magnesium Sulfate, Aspalathus Linearis (Rooibos), Hibiscus Rosa-Sinensis and Camellia Sinensis (White Tea) Extracts1, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) and Cymbopogon Martini (Palmarosa) Oils1


Organic
Fair Trade

Other Information
  • Protect the product in this container from excessive heat and direct sun.

Questions

Call (888) 898-6955 or visit www.Andalou.com

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

NEW

ANDALOU
Naturals
FRUIT STEM CELL SCIENCE

BB
Oil Control
BEAUTY BALM
Un-Tinted
with SPF 30

REGENERATING
FRUIT STEM CELLS

CLARIFYING

FRUIT STEM CELLS
RENEW ■ REPAIR ■ REGENERATE

58 mL e 2 fl oz

ANDALOU BB UNTINTED WITH SPF-30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-0101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
glyceryl monostearate 
sage 
saw palmetto 
willow bark 
pomegranate seed oil 
aloe vera leaf 
zinc gluconate 
medium-chain triglycerides 
sorbitan monostearate 
mandarin oil 
magnesium sulfate 
helianthus annuus flowering top 
jojoba oil 
tocopherol 
magnesium ascorbyl phosphate 
hyaluronate sodium 
palmarosa oil 
phenylethyl alcohol 
ethylhexylglycerin 
Packaging
#Item CodePackage Description
1NDC:55560-0101-158 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/10/2012
Labeler - Andalou naturals (011472720)

Revised: 02/2013
 
Andalou naturals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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