Label: ABSOLUTELY NATURAL BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion

  • NDC Code(s): 70793-020-02, 70793-020-06
  • Packager: Absolutely Natural, Inc.
  • 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 March 22, 2021

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

  • Drug Facts

  • Active ingredient

    Zinc Oxide 18%

  • 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.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask doctor if rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions •

    • Apply liberally and evenly 15 minutes prior to sun exposure.

    • Reapply after 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours.

    • 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 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.

  • Other information •

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients •

    Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate, fragrance.

  • Questions?

    Call us! (800) 848-7623

  • SPL UNCLASSIFIED SECTION

    WATER RESISTANT (40 MINUTES)

    With Rose Hips Oil

    REEF SAFE SINCE 1992

    Please recycle this container.
    This product is biodegradable and reef safe.

    Distributed By: Absolutely Natural, Inc.,
    640 Atlantis Rd, Melbourne, FL 32904
    www.Absolutely-Natural.com

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ABSOLUTELY NATURAL BROAD SPECTRUM SPF 30 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70793-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    RICE BRAN (UNII: R60QEP13IC)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70793-020-0259 mL in 1 TUBE; Type 0: Not a Combination Product03/19/2021
    2NDC:70793-020-06177 mL in 1 TUBE; Type 0: Not a Combination Product03/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/19/2021
    Labeler - Absolutely Natural, Inc. (166425202)