Label: JOURNEE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNCREEN SPF 30- octinoxate and zinc oxide lotion
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NDC Code(s):
46783-002-01,
46783-002-02,
46783-002-03,
46783-002-05, view more46783-002-50
- Packager: Merz North America, 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 January 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
- Higher SPF gives more sunburn protection.
- 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.
- For 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 the 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.
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Inactive Ingredients
Water, Caprylic / Capric Triglyceride, Hydrogenated Poly (C6-14 Olefin), Hexyldecanol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Camellia Sinensis Leaf Extract, Silica, Cutaneous Lysate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylysilane, Disodium EDTA, Xanthan Gum, Styrene / Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 ML Bottle Label
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INGREDIENTS AND APPEARANCE
JOURNEE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNCREEN SPF 30
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46783-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 73 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HEXYLDECANOL (UNII: 151Z7P1317) STEARETH-21 (UNII: 53J3F32P58) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PHENOXYETHANOL (UNII: HIE492ZZ3T) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46783-002-01 1 in 1 CARTON 04/01/2011 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:46783-002-02 1 in 1 CARTON 04/01/2011 2 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:46783-002-03 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2011 4 NDC:46783-002-05 4 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2011 5 NDC:46783-002-50 1 in 1 CARTON 06/18/2019 05/31/2024 5 50 mL in 1 BOTTLE; 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 04/01/2011 Labeler - Merz North America, Inc. (028147846)
