ARBONNE INTELLIGENCE POLLUTION DEFENSE SPF30 CC CREAM - FAIR SHADE- spf30 cc cream - fair shade cream

Arbonne Intelligence Pollution Defense SPF30 CC Cream - Fair Shade by

Drug Labeling and Warnings

Arbonne Intelligence Pollution Defense SPF30 CC Cream - Fair Shade by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC, Autumn Harp, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%

Zinc Oxide 7.2%

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 occurs

KEEP OUT OF REACH OF CHILDREN

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

Directions

For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor
  • 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 specrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

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

Inactive ingredients

Water, Isononyl Isononanoate, Caprylic/Capric Triglyceride, Diisopropyl Sebacate, Cyclopentasiloxane, Dimethicone, Ethylhexyl Palmitate, Polyglyceryl-6 Polyricinoleate, Glycerin, Polymethylsilsesquioxane, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Isopropyl Myristate, Polysilicone-11, Capparis Spinosa Fruit extract, Taraxacum Officinale (Dandelion) Root Extract, Medicago sativa (Alfalfa) Seed Extract, Cichorium Intybus (Chicory) Root Extract, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Tocopherol, Hydrogenated Castor Oil, Bisabolol, Biosaccharide gum-4, ethylhexylglycerin, Polyglyceryl-2 Isostearate, Octyldodecyl Myristate, Stearalkonium Hectorite, magnesium stearate, Sodium Chloride, Isopropyl Titanium Triisostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Silica, Propylene Carbonate, Alumina, Phenoxyethanol. May contain: mica, Titanium Dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499).

Questions or comments?

1.800.272.6663

Monday-Friday 6 a.m.-6 p.m. PST

Package, label, principal display panel

R02_01_AI_PollutionDefenseCCcreamSPF30_comp_FPO.jpg

R02_01_AI_PollutionDefenseCCcreamSPF30_ctn_FPO.jpg

R04_Z1-2-3_PollutionDefense_CCCream_UnitLbl_FPO.jpg

INGREDIENTS AND APPEARANCE

ARBONNE INTELLIGENCE POLLUTION DEFENSE SPF30 CC CREAM - FAIR SHADE 
spf30 cc cream - fair shade cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
POLYSILICONE-15 (UNII: F8DRP5BB29)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CASTOR OIL (UNII: D5340Y2I9G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
MEDICAGO SATIVA LEAF (UNII: HY3L927V6M)
CHICORY ROOT (UNII: 090CTY533N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LEVOMENOL (UNII: 24WE03BX2T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
FARNESOL (UNII: EB41QIU6JL)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CAPPARIS SPINOSA WHOLE (UNII: 4UJ92RL9U7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-226-18	1 in 1 CARTON	09/01/2018
1		34000 mg 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	09/01/2018

Labeler - Arbonne International, LLC (021541164)

Registrant - Autumn Harp, Incorporated (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Incorporated		064187883	manufacture(42508-226)