CREAM- zinc oxide cream 
Oxygen Development LLC

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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MONAT BB CREAM SPF 40 Broad-Spectrum Moisturizer

Active ingredient

Zinc Oxide 18.8%

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

61354-112-aw61354-112-01_aw61354-112_aw

CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.8 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
TRICAPRYLIN (UNII: 6P92858988) 7 mg  in 100 mg
JOJOBA OIL (UNII: 724GKU717M) 2.76 mg  in 100 mg
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 2.04 mg  in 100 mg
RICE BRAN (UNII: R60QEP13IC) 2 mg  in 100 mg
COCO-CAPRYLATE (UNII: 4828G836N6) 1.99 mg  in 100 mg
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) 1.04 mg  in 100 mg
DIMETHICONE (UNII: 92RU3N3Y1O) 1 mg  in 100 mg
TRIHEPTANOIN (UNII: 2P6O7CFW5K) 0.91 mg  in 100 mg
WATER (UNII: 059QF0KO0R) 28.37 mg  in 100 mg
STEARALKONIUM ION (UNII: UMO7T7E1XN) 2.6 mg  in 100 mg
BENTONITE (UNII: A3N5ZCN45C) 0.93 mg  in 100 mg
DODECANE (UNII: 11A386X1QH) 11.96 mg  in 100 mg
BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4) 3.5 mg  in 100 mg
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 1.33 mg  in 100 mg
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 1 mg  in 100 mg
PROPANEDIOL (UNII: 5965N8W85T) 2 mg  in 100 mg
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) 1.2 mg  in 100 mg
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 1.5 mg  in 100 mg
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 1.32 mg  in 100 mg
TRIETHYL CITRATE (UNII: 8Z96QXD6UM) 0.52 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.57 mg  in 100 mg
FERRIC OXIDE RED (UNII: 1K09F3G675) 1.51 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-112-011 in 1 CARTON07/06/2023
1100 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/06/2023
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-112)

Revised: 7/2023
Document Id: ffd74c89-4232-758e-e053-6394a90a7d88
Set id: ffd77e4e-7538-0ad3-e053-6294a90a6005
Version: 1
Effective Time: 20230706
 
Oxygen Development LLC