Cream by MONAT GLOBAL CORP / NuWorld/Cosmax D&B CREAM- zinc oxide cream

Cream by

Drug Labeling and Warnings

Cream by is a Otc medication manufactured, distributed, or labeled by MONAT GLOBAL CORP, NuWorld/Cosmax D&B. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 18.8%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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 damage 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

Directions

• Apply liberally 15 minutes before sun exposure
• Apply to sll skin exposed to the sun
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Sun ProtectionMeasures
  • 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-spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10am-2pm
  • wear a long-sleeved shirt, pants, hat, and sunglasses

INACTIVE INGREDIENT

Inactive Ingredients

Water/Eau, Dodecane, Coco-Caprylate, Tricaprylin, Brassica Napus Extract, Coconut Alkanes, Simmondsia Chinensis (Jojoba) Seed Oil, Stearalkonium Bentonite, Polyglceryl-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 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 77891), Iron Oxides (CI 77491, CI 77492, CI 77499).

STORAGE AND HANDLING

Other information

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

Primary Package

NDC: 78518-002- Primary

Outer Package

78518-002-01- Outer

INGREDIENTS AND APPEARANCE

CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78518-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.8 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J)
PALMITIC ACID (UNII: 2V16EO95H1)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
CASTOR OIL (UNII: D5340Y2I9G)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENTONITE (UNII: A3N5ZCN45C)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
BETAINE (UNII: 3SCV180C9W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRICAPRYLIN (UNII: 6P92858988)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
OLEIC ACID (UNII: 2UMI9U37CP)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
TOCOPHEROL (UNII: R0ZB2556P8)
CARYOCAR BRASILIENSE FRUIT OIL (UNII: WDI9AGC94F)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)
COCONUT ALKANES (UNII: 1E5KJY107T)
POLYGLYCERYL-5 POLYRICINOLEATE (UNII: FT3MR7CR64)
PROPANEDIOL (UNII: 5965N8W85T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
DODECANE (UNII: 11A386X1QH)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
CITRUS LIMON SEED OIL (UNII: T78Z8273XO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
COCO-CAPRYLATE (UNII: 4828G836N6)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
ULVA LACTUCA (UNII: PHR3P25W6Y)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.111 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78518-002-01	1 in 1 CARTON	09/12/2022
1		35 mg 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	09/12/2022

Labeler - MONAT GLOBAL CORP (027036949)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, Corporation		010990210	manufacture(78518-002)