MINERAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide lotion 
COSMECCA KOREA CO., LTD

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Mineral Sunscreen Broad Spectrum SPF30

Drug Facts

Active Ingredients

TITANIUM DIOXIDE 3.44%

ZINC OXIDE 4.88%

PURPOSE

Sunscreen

Uses

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 swallowed. get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

Package Labeling:

Outer PackageInner PackageLabel

MINERAL SUNSCREEN BROAD SPECTRUM SPF30 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53727-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE34.4 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION48.8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
CAFFEINE (UNII: 3G6A5W338E)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ARGAN OIL (UNII: 4V59G5UW9X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
POLYGLYCERYL-10 PENTAOLEATE (UNII: BH1TF96DJC)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53727-121-0150 g in 1 TUBE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/01/2023
Labeler - COSMECCA KOREA CO., LTD (688830827)

Revised: 12/2023
Document Id: 0c5bffd9-f247-8bee-e063-6294a90ac249
Set id: f65441f7-d9a1-2129-e053-2995a90a3f9b
Version: 4
Effective Time: 20231212
 
COSMECCA KOREA CO., LTD