ARGAN STEM CELL BB BENEFIT BALM UN-TINTED SFP 30- zinc oxide lotion

Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30 by

Drug Labeling and Warnings

Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30 by is a Otc medication manufactured, distributed, or labeled by Andalou naturals, Sun Deep Inc. 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.

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.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Daily, alone or under make-up.
• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
• 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.

Non Medicinal Ingredients

Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil1, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil1, Punica Granatum (Pomegranate) Seed Oil1, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Fruit Stem Cells (Argan, Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Sodium Hyaluronate, Salix Alba (Willow Bark) Extract1, Serenoa Rapens (Saw Palmetto) Fruit Extract1, Magnesium Ascorbyl Phosphate (Vitamin C), Borago Officinalis (Borage) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract12, Hibiscus Sabdariffa Flower Extract12, Tocopherol, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Aurantium Dulcis (Orange) Peel Oil1, Cymbopogon Martini (Palmarosa) Leaf Oil1

1 Certified Organic/Organic

2 Fair Trade/Biologique

Other Information

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

Questions

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

SPL UNCLASSIFIED SECTION

Dist. by Andalou Naturals
Novato, CA 94945 USA

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

IMPROVED!

ANDALOU
NATURALS

NON
GMO

BB

Argan Stem Cell
BENEFIT BALM

Un-Tinted
SPF 30

with Argan Stem Cells
Energized Renewal

Broad Spectrum Protection

FRUIT
STEM
CELL

SCIENCE®

CLEAR SKIN

NPN 80042784

2 fl oz e 58 mL

INGREDIENTS AND APPEARANCE

ARGAN STEM CELL BB BENEFIT BALM UN-TINTED SFP 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-0109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
APPLE (UNII: B423VGH5S9)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ACAI (UNII: 46AM2VJ0AW)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WILLOW BARK (UNII: S883J9JDYX)
SAW PALMETTO (UNII: J7WWH9M8QS)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
BORAGE SEED OIL (UNII: F8XAG1755S)
CUCUMBER (UNII: YY7C30VXJT)
STARCH, CORN (UNII: O8232NY3SJ)
WHITE TEA (UNII: O0M3396E09)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ORANGE OIL (UNII: AKN3KSD11B)
PALMAROSA OIL (UNII: 0J3G3O53ST)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-0109-1	1 in 1 CARTON	12/10/2012
1		58 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	part352	12/10/2012

Labeler - Andalou naturals (011472720)