![JOURNEE RICHE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNSCREEN SPF 30 (OCTINOXATE AND ZINC OXIDE) LOTION [MERZ NORTH AMERICA, INC.]](https://medic.hrt.org//dailymed/images/3fb5bd27-b890-445b-b6da-9f64dcc286f3/journee-01.jpg)
| NDC | 46783-175-01, 46783-175-04, 46783-175-05, 46783-175-10, 46783-175-15 |
| Set ID | 3fb5bd27-b890-445b-b6da-9f64dcc286f3 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Merz North America, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- Helps prevent sunburn and premature skin aging.
- 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
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Directions
- Apply generously 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a 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 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-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months of age, ask a doctor
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Inactive ingredients
Water, Hydrogenated Polyisobutene, Petrolatum, Caprylic/Capric Triglyceride, Hexyldecanol, Isododecane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Dioscorea Villosa (Wild Yam) Root Extract, Camellia Sinensis Leaf Extract, Silica, Cutaneous Lysate (PSP®), Butylene Glycol, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylsilane, Polysilicone-11, Disodium EDTA, Xanthan Gum, Cellulose Gum, Styrene/Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton
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INGREDIENTS AND APPEARANCE
JOURNEE RICHE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNSCREEN SPF 30
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46783-175 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.3 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PETROLATUM (UNII: 4T6H12BN9U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HEXYLDECANOL (UNII: 151Z7P1317) ISODODECANE (UNII: A8289P68Y2) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW) SQUALANE (UNII: GW89575KF9) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) STEARETH-21 (UNII: 53J3F32P58) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 60 (UNII: CAL22UVI4M) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46783-175-05 1 in 1 CARTON 05/18/2015 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:46783-175-10 1 in 1 CARTON 05/18/2015 2 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:46783-175-15 1 in 1 CARTON 05/18/2015 3 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:46783-175-01 1 mL in 1 PACKET; Type 0: Not a Combination Product 05/18/2015 07/01/2020 5 NDC:46783-175-04 4 mL in 1 TUBE; Type 0: Not a Combination Product 05/18/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/18/2015 Labeler - Merz North America, Inc. (028147846)
