Otc - Active Ingredient
Active Ingredient
Zinc Oxide 18.8%
Cream
FDA Label NDC 78518-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Monat Global Corp for the product Cream (NDC 78518-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Otc - Do Not Use
Do not use on damage or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.
Directions
Directions
- Apply liberally 15 minutes before sun exposure
- Apply to sll skin exposed to the sun
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Sun ProtectionMeasures
- 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 10am-2pm
- wear a long-sleeved shirt, pants, hat, and sunglasses
Inactive Ingredient
Inactive Ingredients
Water/Eau, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglceryl-3 Polyricinoleate, Oryza sativa (Rice) Bran Extract, Propanediol, Caprylic/Capric Triglyceride, Glyceryl Caprylate, Coco-caprylate/Caprate, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone, Cocos Nucifera (Coconut) Oil, Citrus Limon (Lemon) Peel Oil, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Tremella Fuciformis Sporocarp Extract, Camellia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanthes Alba (Meadowfoam) Seed Oil, Crambe Abyssinica Seed Oil, Camellia Oleifera Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Daucus Carota Sativa (Carrot) Seed Oil, Phytosteryl Canola Glycerides, Oleic Acid, Palmitic Acid, Stearic Acid, Triolein, Tocopherol, Adansonia Digitata Oil, Mauritia Flexuosa Fruit Oil, Gardenia Taitensis Flower Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Tocopherol Acetate, Ulva Lactuca Extract, Jojoba Esters, Polyglyceryl-6 Polyricinoleate, Silica, Triethyl Citrate, Glycerin, Betain, Glyceryl Undecylenate, Potassium Sorbate, Sodium Benzoate, Bentonite, May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).
Storage And Handling
Other information
- Protect the product in this container from excessive heat and direct sun.
Primary Package(Tube)
Tube
Outer Package(Carton)
Carton- Outer Package
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