Active Ingredient
Zinc Oxide 18.8%
Cream
FDA Label NDC 61354-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development Llc for the product Cream (NDC 61354-113). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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
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
Warnings
For external use only
Do Not Use
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 A Doctor
Stop use and ask a doctor if rash occurs
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a poison control center right away
Directions
Apply liberally 15 minutes before sun exposure.
Apply to all skin exposed to the sun.
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 the risk, regularly use a sunscreen with a board-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 a long-sleeved shirt, pants, hat, and sunglasses
Inactive Ingredient
Water, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglyceryl-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 Aurantofolia (Lime) Oil, Citrus Aurantium Bergamia (Bergamot)Fruit Oil, Tremella Fucformis Sporocarp Extract, Camelia Sinensis Leaf Extract, Linoleic Acid, Lecithin, Limnanther Alba (Meadowfoam (Speed Oil, Crambe Abyssinica Seed Oil, Camelia 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, Maurita Flexuosa Fruit Oil, Gardenia Taitensis Flowe Extract, Moringa Oleifera Seed Oil, Caryocar Brasiliense Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europea (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 77492), Iron Oxides (CI 77491, CI 77492, CI 77499)
Other Information
Protect the product in this container from excessive heat and direct sun
* Please review the disclaimer below.
