JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT RADIANCE- zinc oxide, titanium dioxide lotion

Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect Radiance by

Drug Labeling and Warnings

Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect Radiance by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

(What is this?)

Drug Facts

Active Ingredients

Zinc Oxide 9.4%**

Titanium Dioxide 5.9%**

Purpose

Sunscreen

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.

Stop use and ask a doctor if rash occurs.

When using this product

· keep out of eyes

· Rinse with water to remove

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

Directions:

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

WHEN USING

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10am - 2pm.

Wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients:

Aqua (Water)**, Caprylic/Capric Triglyceride**, Ethylhexyl Palmitate**, Titanium Dioxide**, Cyclopentasiloxane, Argania Spinosa (Argan) Kernel Oil**, Polyglyceryl-6 Polyricinoleate**, Mica**, Nylon-12, Glycerin**, Polyhydroxystearic Acid, Polyglyceryl-2 Isostearate, Methicone, Alumina, Phenoxyethanol, Isononyl Isononanoate, Disteardimonium Hectorite, Tocopheryl Acetate, Triethoxycaprylylsilane, Polysilicone-11, Sodium Chloride**, Iron Oxide (CI 77492)**, Bismuth Oxychloride, Magnesium Stearate**, Isopropyl Myristate, Fragrance**, Bisabolol, Iron Oxides (CI 77491)**, Cochineal, Aloe Barbadensis Leaf Juice*, Simmondsia Chinensis (Jojoba) Seed Oil*, Tin oxide (CI 77861)**, Isopropyl Titanium Triisostearate, Iron Oxides (CI 77499)**, Stearalkonium Hectorite, Propylene Carbonate, Laureth-12, Camellia Sinensis (Green Tea) Leaf Extract**, Tocopherol**, Ethylhexylglycerin, Citric Acid**, Potassium Sorbate**, Sodium Benzoate**.

* Organic ** Natural

Other Information:

· Protect this product from excessive heat and direct sun.

Principle Display Panel

INGREDIENTS AND APPEARANCE

JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT RADIANCE 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.4 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X)
MICA (UNII: V8A1AW0880)
ARGAN OIL (UNII: 4V59G5UW9X)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSILICONE-15 (UNII: F8DRP5BB29)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
APRICOT (UNII: 269CJD5GZ9)
LEVOMENOL (UNII: 24WE03BX2T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
JOJOBA OIL (UNII: 724GKU717M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
LINALOOL, (+)- (UNII: F4VNO44C09)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LAURETH-12 (UNII: OAH19558U1)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TOCOPHEROL (UNII: R0ZB2556P8)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
COCHINEAL (UNII: TZ8Z31B35M)
STANNIC OXIDE (UNII: KM7N50LOS6)
FARNESOL (UNII: EB41QIU6JL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0355-1	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/24/2014
2	NDC: 51514-0355-2	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/24/2014
3	NDC: 51514-0355-3	15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/24/2014
4	NDC: 51514-0355-4	177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/24/2014

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0355)