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 February 21, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    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.

  • DOSAGE & ADMINISTRATION

  • KEEP OUT OF REACH OF CHILDREN

  • ASK DOCTOR/PHARMACIST

    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

  • WHEN USING

    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

  • INACTIVE INGREDIENT

    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 ml240 ml

  • INGREDIENTS AND APPEARANCE
    DESERVING HEALTH NATURAL SUNBLOCK 
    octocrylene,octyl methoxycinnamate,octyl salicylate,oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-902-01120 mL in 1 TUBE; Type 0: Not a Combination Product02/21/2020
    2NDC:69711-902-02240 mL in 1 TUBE; Type 0: Not a Combination Product02/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/21/2020
    Labeler - Deserving Health International Corp. (079767886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deserving Health International Corp.202617023manufacture(69711-902)