1000 ROSES CC COLOR PLUS CORRECT SHEER BEIGE SPF 30- zinc oxide lotion

1000 Roses CC Color plus Correct Sheer Beige SPF 30 by

Drug Labeling and Warnings

1000 Roses CC Color plus Correct Sheer Beige SPF 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

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Magnesium Sulfate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Castor Oil, Hydrogenated Methyl Abietate, Stearyl/Octyldodecyl Citrate Crosspolymer, Caprylhydroxamic Acid, Glyceryl Caprylate, Rhododendron Ferrugineum (Alpine Rose) Leaf Cell Culture Extract, Malus Domestica (Apple) Fruit Cell Culture Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Sodium Hyaluronate, Simmondsia Chinensis (Jojoba) Seed Oil1, Helianthus Annuus (Sunflower) Seed Oil1, Aronia Melanocarpa (Black Chokeberry) Fruit Extract1, Lycium Barbarum (Goji) Fruit Extract1, Euterpe Oleracea (Açai) Fruit Extract1, Camellia Sinensis (Tea) Leaf Extract1, Isomalt, Soy Lecithin, Tocopherol, Galactoarabinan, Xanthan Gum, Sodium Benzoate, Ethylhexylglycerin, Natural Fragrance, Iron Oxides (CI 77491, CI 77492, Cl 77499).

1 Certified Organic Ingredient.

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

MINERAL SUNSCREEN

ANDALOU
NATURALS

CC

1000 Roses®
COLOR + CORRECT

Sheer Beige

SPF 30

Alpine Rose Stem Cells +
Hyaluronic Acid + Vitamin E

Broad Spectrum SPF 30

FRUIT
STEM
CELL
SCIENCE®

SENSITIVE

NPN 80051204

2 fl oz / 58 mL

INGREDIENTS AND APPEARANCE

1000 ROSES CC COLOR PLUS CORRECT SHEER BEIGE SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55560-0110
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
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)
APPLE (UNII: B423VGH5S9)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ACAI (UNII: 46AM2VJ0AW)
TEA LEAF (UNII: GH42T47V24)
ISOMALT (UNII: S870P55O2W)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
TOCOPHEROL (UNII: R0ZB2556P8)
GALACTOARABINAN (UNII: SL4SX1O487)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55560-0110-1	1 in 1 CARTON	03/01/2014
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 DRUG	M020	03/01/2014

Labeler - Andalou naturals (011472720)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc		189788201	MANUFACTURE(55560-0110)