Label: HERMES PLEIN AIR NATURAL ENHANCING COMPLEXION BALM SPF 30 SUNSCREEN 50 PALOMINO- titanium dioxide cream

  • NDC Code(s): 82494-005-01, 82494-005-17, 82494-005-40
  • Packager: COMPTOIR NOUVEAU DE LA PARFUMERIE
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active ingredient

    Titanium Dioxide 12,4%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Children under 6 months age: Ask a doctor.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Reapply immediately after towel drying.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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 10 a.m-2 p.m. • Wear long-sleeved shirts, hats, and sunglasses. Sun Protection Measures.

  • Inactive ingredients

    AQUA (WATER), METHYL TRIMETHICONE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, DIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, CYCLOPENTASILOXANE, VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER, PENTYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, POLYGLYCERYL-2 DIISOSTEARATE, SORBITOL, PARFUM (FRAGRANCE), DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, SODIUM CITRATE, SODIUM CHLORIDE, STEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, TOCOPHEROL, GLYCINE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BENZYL SALICYLATE, SODIUM HYALURONATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, LIMONENE, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, MORUS ALBA BARK EXTRACT, GERANIOL,  CITRONELLOL, LINALOOL, HYDROXYCITRONELLAL [+/- (MAY CONTAIN) : MICA, CI 77891 (TITANIUM DIOXIDE), CI 77491/CI 77492/ CI 77499 (IRON OXIDES)].

  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Package Labeling:82494-005-01

    Box0Box02

  • Package Labeling:82494-005-17

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  • Package Labeling:82494-005-40

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  • INGREDIENTS AND APPEARANCE
    HERMES PLEIN AIR NATURAL ENHANCING COMPLEXION BALM SPF 30 SUNSCREEN 50 PALOMINO 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82494-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE124 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    SORBITOL (UNII: 506T60A25R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCINE (UNII: TE7660XO1C)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82494-005-011 mL in 1 BAG; Type 0: Not a Combination Product01/15/2022
    2NDC:82494-005-171 in 1 CARTON01/15/2022
    217 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:82494-005-401 in 1 CARTON01/15/2022
    340 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/15/2022
    Labeler - COMPTOIR NOUVEAU DE LA PARFUMERIE (275137834)
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