Active Ingredient
ZINC OXIDE 1%
TITANIUM DIOXIDE 2%
One And Done
FDA Label NDC 82735-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Thirteen Lune Inc. for the product One And Done (NDC 82735-200). 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, warnings, uses, directions, questions, inactive ingredients, 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
Purpose
SUNSCREEN
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 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.
Keep outer carton for complete labeling information.
Uses
Helps prevent sunburn.
If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin againg caused by the sun.
Directions
Apply liberally 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 increased your risk of skin cancer and early skin aging. To decrease this rick, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measure including:
- Limit time in the sun, especially from 10 a.m. - 2p.m.
- Wear long sleeve shirts, pants, hats and sunglasses.
Children under 6 months: Ask a doctor
Questions
(888) 305-2032
Inactive Ingredients
Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol Diheptanoate, Niacinamide, Cetyl Alcohol, Glyceryl Stearate, Squalane, PEG-75 Stearate, Phenoxyethanol, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl, Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/Silicate Crosspolymer, Allantoin, Caprylyl Glycol, Hippophae Rhamnoides Seed Oil, Prunus, Domestica Seed Oil, Mauritia Flexuosa Fruit Oil, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Ethylhexylglycerin, Hexylene Glycol, Sodium Hyaluronate, Trilaureth-4 Phosphate, Butylene Glycol, Disodium EDTA, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Plankton Extract, Lecithin, Silica, Avena Sativa (Oat) Kernel Extract, Kigelia Africana Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Ascorbate, Tocopherol.
Otc - Keep Out Of Reach Of Children
​KEEP OUT OF REACH OF CHILDREN.
Principal Display Panel
Primary Packaging Artwork (Primary)
50ML RELEVANT ONE + DONE 50ML
15ml Primary Packaging Artwork (15ml)
15ML RELEVANT ONE + DONE SPF
4ML RELEVANT ONE + DONE SACHET (SAMPLE)
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