Label: JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT RADIANCE- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0355-1, 51514-0355-2, 51514-0355-3, 51514-0355-4 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 8, 2019
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- BOXED WARNING (What is this?)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions:
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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
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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:
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 PROTECT AND PERFECT RADIANCE
zinc oxide, titanium dioxide lotionProduct 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)