Label: CLOUD 9 100% MINERAL SUN BALM BROAD SPECTRUM SUNSCREEN SPF 40- titanium dioxide, zinc oxide cream

  • 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 October 20, 2022

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

  • Active Ingredients

    Titanium Dioxide 1.14%, Zinc Oxide 20.4% 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • Warnings

    For external use only. Do not use on damaged or broken skin. When using the product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Apply generously and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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: Ask a doctor
  • Inactive Ingredients

    Adansonia Digitata (Baobab) Seed Oil, Astrocaryum Murumuru Seed Butter, Butyrospermum Parkii (Shea) Butter, C9-12 Alkane, Calendula Officinalis (Calendula) Extract, Caprylic/Capric Triglyceride, Cetyl Esters, Coco-Caprylate/Caprate, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Seed Wax, Hippophae Rhamnoides (Sea Buckthorn) Seed Oil, Hydrogenated Rapeseed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Rosa Alba (White Rose) Leaf Cell Extract, Rosa Canina (Rose Hip) Fruit Oil, Silica, Stearic Acid

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun

    Questions or commnets? Contact our Sun Specialists 877-564-7330

  • PRINCIPAL DISPLAY PANEL

    CLOUD 9

    100% MINERAL SUN BALM

    Broad Spectrum Sunscreen SPF 40 PA+++

    Cloud 9 100% Mineral Sun Balm SPF 40 is a pocket-friendly formula that leaves your skin feeling like it's on, well, cloud nine. Use it wherever you need some serious protection, soothing and nourishment, but definitely don't forget about spots like your ears and hands that may require little extra TLC.

    supergoop.com Distributed by Taylor James, LLC. San Antonio, TX 78215

    SPF 40

    Cruelty free

    1 oz./28.7g

    100% Mineral Sunscreen Actives. Reef-Safe. Non-Irritating. No Synthetic Fragrance. Vegan.

    Sun Balm SPF40

    SPF 40

  • INGREDIENTS AND APPEARANCE
    CLOUD 9 100% MINERAL SUN BALM BROAD SPECTRUM SUNSCREEN SPF 40 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.14 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    1,3-BUTYLENE GLYCOL 1-STEARATE (UNII: UZQ17K3ERJ)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-512-0128.7 g in 1 CONTAINER; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/20/2020
    Labeler - Supergoop, LLC (117061743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gordon Laboratories, Inc008328619manufacture(75936-512)