ANDALOU BB UNTINTED WITH SPF-30- zinc oxide lotion

Andalou BB Untinted with SPF-30 by

Drug Labeling and Warnings

Andalou BB Untinted with SPF-30 by is a Otc medication manufactured, distributed, or labeled by Andalou naturals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 Juice1, 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) Extracts12, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) and Cymbopogon Martini (Palmarosa) Oils1

1 Organic

2 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

INGREDIENTS AND APPEARANCE

ANDALOU BB UNTINTED WITH SPF-30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-0101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
glyceryl monostearate (UNII: 230OU9XXE4)
sage (UNII: 065C5D077J)
saw palmetto (UNII: J7WWH9M8QS)
willow bark (UNII: S883J9JDYX)
pomegranate seed oil (UNII: 0UI45XV0T6)
aloe vera leaf (UNII: ZY81Z83H0X)
zinc gluconate (UNII: U6WSN5SQ1Z)
medium-chain triglycerides (UNII: C9H2L21V7U)
sorbitan monostearate (UNII: NVZ4I0H58X)
mandarin oil (UNII: NJO720F72R)
magnesium sulfate (UNII: DE08037SAB)
helianthus annuus flowering top (UNII: BKJ0J3D1BP)
jojoba oil (UNII: 724GKU717M)
tocopherol (UNII: R0ZB2556P8)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
hyaluronate sodium (UNII: YSE9PPT4TH)
palmarosa oil (UNII: 0J3G3O53ST)
phenylethyl alcohol (UNII: ML9LGA7468)
ethylhexylglycerin (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-0101-1	58 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/10/2012

Labeler - Andalou naturals (011472720)