RADIANCESHIELD UNTINTED LOTION [THE SKIN ATELIER, INC.]

RADIANCESHIELD UNTINTED LOTION [THE SKIN ATELIER, INC.]
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NDC 71393-016-34
Set ID 6d5d8bde-dd57-7919-e053-2991aa0a637b
Category HUMAN OTC DRUG LABEL
Packager The Skin Atelier, Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredients: Zinc Oxide (10.5%), Titanium Dioxde (4.4%)

  • INSTRUCTIONS FOR USE

    Apply in the morning, as the last product in your regiment or as needed, at least every 2 hours if in direct sunlight. 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 limiting time in the sun, especially from 10 a.m. to 2 p.m., wear long sleeved shirts, pants, hats and sunglasses, children under 6 months of age: ask a doctor.

  • DOSAGE & ADMINISTRATION

    Apply in the morning, as the last product in your regiment or as needed, at least every 2 hours if in direct sunlight. 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 limiting time in the sun, especially from 10 a.m. to 2 p.m., wear long sleeved shirts, pants, hats and sunglasses, children under 6 months of age: ask a doctor.

  • WARNINGS

    For external use only. Do not use on damaged or broken. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out if reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    For external use only. Do not use on damaged or broken. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out if reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water, Butyloctyl Salicylate, Fatty Alcohol, Ethoxylated Sorbitan Ester, Sodium Hyaluronate, TRIETHOXYCAPRYLYLSILANE, Polysorbate 60, Heptyl Undecylenate, 4-t-Butylcyclohexanol, Dimethicone, Ethylhexyl Methoxycrylene, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Sodium Benzoate, BENZYL ALCOHOL, BENZOIC ACID, SORBIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, pOLYHYDROXYSTEARIC ACID, ALUMINA, STEARIC ACID, Butylene Glycol, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Ubiquinone, Tocopheryl Acetate, C12-15 Alkyl Benzoate, Phenoxyethanol, Disodium EDTA, NIACINAMIDE, Bisabolol, Hydroxymethoxyphenyl Decanone, Butylated hydroxytoluene, sODIUM ascorbyl phosphate

  • INDICATIONS & USAGE

    Helps prevent suburn if used as directed with other sun protection measures (see DIRECTIONS). Decreases risk of skin cancaer and early skin aging caused by the sun.

  • PURPOSE

    Helps prevent suburn if used as directed with other sun protection measures (see DIRECTIONS). Decreases risk of skin cancaer and early skin aging caused by the sun.

  • PRINCIPAL DISPLAY PANEL

    sp-RadianceShield-labelUNTINTED.jpg

  • INGREDIENTS AND APPEARANCE
    RADIANCESHIELD UNTINTED 
    radianceshield untinted lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71393-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAESALPINIA SPINOSA WHOLE (UNII: O759MFY23D)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    4-TERT-BUTYLCYCLOHEXANOL, CIS- (UNII: L5067JRJ73)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    2,3-DICHLOROBENZOIC ACID (UNII: CGP39QV5WF)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    4-HYDROXYBENZYL ALCOHOL (UNII: 1A3AH1FP1B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71393-016-34115 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2018
    Labeler - The Skin Atelier, Inc. (135049810)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Skin Atelier, Inc.135049810manufacture(71393-016)

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