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

  • NDC Code(s): 70793-034-03, 70793-034-10
  • Packager: Absolutely Natural
  • 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 24%

  • 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

    Aloe barbadensis leaf juice, caprylic/capric triglyceride, polyhydroxystearic acid, water, ethylhexyl olivate, squalane, isoamyl laurate, lauryl laurate, sorbitan olivate, copernicia cerifera (carnauba) wax, oryza sativa (rice) bran wax, c13-15 alkane, disteardimonium hectorite, polyglyceryl-3 polyricinoleate, hydrogenated rapeseed oil, capryloyl glycerin/sebacic acid copolymer, silica, propanediol, citrullus lanatus (watermelon) seed oil, butyrospermum parkii (shea) butter, rosa canina fruit oil, cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, camellia sinensis leaf extract, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.

  • Questions?

    Call us! 800-848-7623

  • SPL UNCLASSIFIED SECTION

    EST.1992

    Sheer Finish

    Mineral Sunscreen

    Water Resistant (80 Minutes)

    Vegan

    REEF SAFE

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

    absolutely-natural.com

    crueltyfree

    MADE IN USA

  • Packaging

    Sunscreen-034

  • INGREDIENTS AND APPEARANCE
    ABSOLUTELY NATURAL BROAD SPECTRUM SPF 50PLUS SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70793-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL OLEATE (UNII: R34927QY59)  
    SQUALANE (UNII: GW89575KF9)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    RICE BRAN (UNII: R60QEP13IC)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ROSEMARY (UNII: IJ67X351P9)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70793-034-0388.72 mL in 1 TUBE; Type 0: Not a Combination Product05/22/2023
    2NDC:70793-034-1010 mL in 1 PACKET; Type 0: Not a Combination Product05/22/2023
    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(70793-034)
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