ONE AND DONE- spf 40 cream 
Thirteen Lune Inc.

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.

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Active Ingredient

ZINC OXIDE 1%

TITANIUM DIOXIDE 2%

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:

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.

​KEEP OUT OF REACH OF CHILDREN.

Principal Display Panel

Primary Packaging Artwork

50ML RELEVANT ONE + DONE 50ML

15ML PRIMARY PACKAGING ARTWORK

15ML RELEVANT ONE + DONE SPF

4ML PRIMARY PACKAGING ARTWORK

4ML RELEVANT ONE + DONE SACHET (SAMPLE)

ONE AND DONE 
spf 40 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82735-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82735-200-0150 mL in 1 TUBE; Type 0: Not a Combination Product05/30/2022
2NDC:82735-200-0215 mL in 1 TUBE; Type 0: Not a Combination Product06/15/2022
3NDC:82735-200-034 mL in 1 PACKET; Type 0: Not a Combination Product06/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/30/2022
Labeler - Thirteen Lune Inc. (118111872)

Revised: 5/2022
Document Id: dfdd038b-04ae-2431-e053-2995a90a77c5
Set id: dfc98ed9-5eb8-477a-e053-2995a90a8316
Version: 2
Effective Time: 20220525
 
Thirteen Lune Inc.