MONAT BB CREAM SPF 40 BROAD SPECTRUM MOISTURIZER CAPPUCCINO- zinc oxide cream

Monat BB Cream SPF 40 Broad Spectrum Moisturizer Cappuccino by

Drug Labeling and Warnings

Monat BB Cream SPF 40 Broad Spectrum Moisturizer Cappuccino by is a Otc medication manufactured, distributed, or labeled by Cosmax Usa, Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

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.

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 this risk, regularly use a sunscreen with a broad-soectrum SPF value of 15 or higher and other sun protection measures including: 
• limit time in the sun, especialyy from 10 a.m.-2 p.m.
• wear a long-sleeved shirts, pants, hat, and sunglasses.

Inactive Ingredients

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, Coco 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 77492), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information

• Protect the product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free: 1-888-867-9987 (US)

Package Labeling:

INGREDIENTS AND APPEARANCE

MONAT BB CREAM SPF 40 BROAD SPECTRUM MOISTURIZER CAPPUCCINO 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	188 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DODECANE (UNII: 11A386X1QH)
COCO-CAPRYLATE (UNII: 4828G836N6)
TRICAPRYLIN (UNII: 6P92858988)
BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)
COCONUT ALKANES (UNII: 1E5KJY107T)
JOJOBA OIL (UNII: 724GKU717M)
RICE BRAN (UNII: R60QEP13IC)
PROPANEDIOL (UNII: 5965N8W85T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCONUT OIL (UNII: Q9L0O73W7L)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
CAMELLIA OIL (UNII: T1PE06G0VE)
TOMATO SEED OIL (UNII: 7N87T9C06T)
CARROT SEED OIL (UNII: 595AO13F11)
OLEIC ACID (UNII: 2UMI9U37CP)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
TOCOPHEROL (UNII: R0ZB2556P8)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CARYOCAR BRASILIENSE FRUIT OIL (UNII: WDI9AGC94F)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
DILINOLEIC ACID (UNII: 5RP695IQQ3)
BUTANEDIOL (MIXED ISOMERS) (UNII: TMS4MGA0H4)
CASTOR OIL (UNII: D5340Y2I9G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ULVA LACTUCA (UNII: PHR3P25W6Y)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENTONITE (UNII: A3N5ZCN45C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-056-01	1 in 1 CARTON	10/03/2022
1		35 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/03/2022

Labeler - Cosmax Usa, Corporation (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax Usa, Corporation		010990210	manufacture(68577-056)