Label: DESERVING HEALTH NATURAL SUNBLOCK- octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 21, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    • Octocrylene 4%
    • Octyl Methoxycinnamate 7.5%,
    • Octyl Salicylate 4%,
    • Oxybenzone 5%
  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • 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

    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 15 minutes before sun exposure • Reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
    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 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, pants, hats, and sunglasses • children under 6 months of age: ask a doctor

  • Ingredients

    Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.

  • PRINCIPAL DISPLAY PANEL - 120 ml Tube

    DESERVING HEALTH
    Natural Age-Free Facial Sunblock
    With Certified Organic Ingredients

    Moisturizing with Vitamins A, C, E & Aloe

    UVA+UVB Protection
    Water Resistant (40 minutes)
    Biodegradable
    PABA Free

    For All Skin Types

    Broad Spectrum
    SPF 30+

    Net 4 fl. Oz (120 ml)

    Label 120 ml

  • PRINCIPAL DISPLAY PANEL - 240 ml Tube

    DESERVING HEALTH
    Natural Sunblock
    With Certified Organic Ingredients
    Moisturizing with Vitamins A, C, E & Aloe
    UVA+UVB Protection
    Water Resistant (40 minutes)
    Biodegradable
    PABA Free
    For All Skin Types
    Broad Spectrum
    SPF 30+
    Net 8 fl. Oz (240 ml)

    240 ml Label

  • INGREDIENTS AND APPEARANCE
    DESERVING HEALTH NATURAL SUNBLOCK 
    octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-301-01120 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2017
    2NDC:69711-301-02240 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/20/2017
    Labeler - Deserving Health International Corp (079767886)
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