Label: ABSOLUTELY NATURAL BROAD SPECTRUM SPF 50 SUNSCREEN- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 22, 2023

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 19%

  • 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 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 right away.

  • Directions

    • Apply liberally and evenly 15 minutes prior to sun exposure.
    • Reapply after 80 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

    Cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed wax, olea europaea (olive) oil unsaponifiables, rhus verniciflua peel wax, shorea robusta resin, lauryl laurate, polyhydroxystearic acid, theobroma cacao (cocoa) seed butter, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, calcium silicate, argania spinosa kernel oil, tocopheryl acetate, bisabolol, butyrospermum parkii (shea) butter, glyceryl caprylate, glyceryl undecylenate, citrus aurantium dulcis peel wax, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol.

  • Questions?

    Call us! 800-848-7623

  • SPL UNCLASSIFIED SECTION

    EST. 1992

    Mineral Sunscreen

    Water Resistant (80 Minutes)

    Vegan

    MINERAL FACE & BODY STICK helps prevent sunburn and is infused with nutrients to help keep your skin nourished while in the sun.

    √ Reef Safe

    √ Sensitive Skin

    √ Fragrance Free

    √ Biodegradable

    √ No Harsh Chemicals

    Crueltyfree

    MADE IN USA

    Manufactured by: Absolutely Natural 640 Atlantis Road, Melbourne, FL 32904

    www. Absolutely-Natural.com

  • Packaging

    Sunscreen-035

  • INGREDIENTS AND APPEARANCE
    ABSOLUTELY NATURAL BROAD SPECTRUM SPF 50 SUNSCREEN 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70793-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    RICE BRAN (UNII: R60QEP13IC)  
    ROSEMARY (UNII: IJ67X351P9)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70793-035-681 in 1 CARTON05/22/2023
    119.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/22/2023
    Labeler - Absolutely Natural (166425202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Absolutely Natural166425202manufacture(70793-035)
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