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| Product NDC Code | 75936-512 | ||||
|---|---|---|---|---|---|
| Drug Name | Cloud 9 100% mineral sun balm broad spectrum sunscreen spf 40 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Supergoop, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 1.14%, Zinc Oxide 20.4% Purpose Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Cloud 9 100% Mineral Sun Balm Broad Spectrum Sunscreen SPF 40 Titanium Dioxide, Zinc Oxide 1,3-BUTYLENE GLYCOL 1-STEARATE HIPPOPHAE RHAMNOIDES FRUIT OIL HELIANTHUS ANNUUS SEED WAX HYDROGENATED RAPESEED OIL POLYHYDROXYSTEARIC ACID (2300 MW) SHEA BUTTER MAURITIA FLEXUOSA FRUIT OIL ASTROCARYUM MURUMURU SEED BUTTER CALENDULA OFFICINALIS FLOWER PUNICA GRANATUM SEED OIL CETYL ESTERS WAX COCO-CAPRYLATE/CAPRATE SUNFLOWER OIL ADANSONIA DIGITATA SEED OIL COCONUT OIL ROSA CANINA FRUIT OIL SILICON DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Protect the product in this container from excessive heat and direct sun Questions or commnets? Contact our Sun Specialists 877-564-7330
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API