CREAM- zinc oxide cream 
MONAT GLOBAL CORP

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BB Cream SPF 40 Broad-Spectrum Moisturizer (Vanilla)

Active Ingredient

Zinc Oxide 18.8%

Purpose

Sunscreen

Uses

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

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).

Other information

Primary Package

Tube Tube

Secondary Package

Secondary Pkg SP-Vanilla

CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78518-010
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
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
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78518-010-011 in 1 CARTON09/12/2022
135 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/12/2022
Labeler - MONAT GLOBAL CORP (027036949)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax Usa, Inc.010990210manufacture(78518-010)

Revised: 1/2024
Document Id: 0bddacdb-6b6d-1142-e063-6394a90ae230
Set id: e92364b2-b065-b2ff-e053-2a95a90a45fa
Version: 2
Effective Time: 20240111
 
MONAT GLOBAL CORP