JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47- zinc oxide, titanium dioxide lotion

Josie Maran Argan Daily Moisturizer SPF47 by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active Ingredients

Zinc Oxide 6.4%**

Titanium Dioxide 5.1%**

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)**, Ethylhexyl Palmitate, Caprylic/Capric

Triglyceride**, Aloe Barbadensis Leaf Juice*, Polyglyceryl-6

Polyricinoleate**, Cyclopentasiloxane, Polysilicone-11,

Argania Spinosa (Argan) Kernel Oil**, Glycerin**, Cera Alba

(Beeswax)*, Coco-Caprylate/Caprate, Phenoxyethanol,

Polyhydroxystearic Acid, Methicone, Alumina, Tocopheryl

Acetate, Sodium Chloride**, Triethoxycaprylylsilane,

Polyglyceryl-10 Laurate, Parfum (Fragrance)**, Bisabolol,

Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil*,

Laureth-12, Ethylhexylglycerin, Camellia Sinensis (Green

Tea) Leaf Extract*, Citric Acid**, Potassium Sorbate**,

Sodium Benzoate**.

*ORGANIC **NATURAL

Other Information:

· Protect this product from excessive heat and direct sun.

Principle Display Panel

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INGREDIENTS AND APPEARANCE

JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.4 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X)
POLYSILICONE-15 (UNII: F8DRP5BB29)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
YELLOW WAX (UNII: 2ZA36H0S2V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
APRICOT (UNII: 269CJD5GZ9)
LEVOMENOL (UNII: 24WE03BX2T)
JOJOBA OIL (UNII: 724GKU717M)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURETH-12 (UNII: OAH19558U1)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0332-1	5 mL in 1 TUBE; Type 0: Not a Combination Product	01/24/2014
2	NDC: 51514-0332-2	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/24/2014
3	NDC: 51514-0332-3	60 mL in 1 TUBE; Type 0: Not a Combination Product	01/24/2014
4	NDC: 51514-0332-4	120 mL in 1 TUBE; 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	01/09/2014

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0332)