MINERAL KIDCREME SPF 50- titanium dioxide and zinc oxide cream 
MDSolarSciences

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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Mineral KidCrème® SPF 50
Mineral Broad Spectrum Sunscreen SPF 50 Water Resistant (80 min)

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 2%Sunscreen
Zinc Oxide 17%Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Shake well. Rub in well.

Inactive Ingredients

Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/ Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polysilicone-15, Punica Granatum Extract (Pomegranate), Vaccinium Macrocarpon (Cranberry) Fruit Extract, Ubiquinone (CoQ10), Camellia Sinensis Leaf Extract (Green Tea), Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Squalane, Polyhydroxystearic Acid, Silica, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499).

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton

MDSOLARSCIENCES®

PROTECT & NOURISH

MINERAL
KIDCRÈME®

Broad Spectrum Sunscreen SPF 50
Water Resistant (80 Min)

SPF
50

Natural, sheer protection
for humans 6 months + older

DERMATOLOGIST DEVELOPED

3.4 FL OZ / 100 ML

PRINCIPAL DISPLAY PANEL - 100 ML Tube Carton
MINERAL KIDCREME SPF 50 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-584
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE170 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
POMEGRANATE JUICE (UNII: 99S671U9KB)  
CRANBERRY (UNII: 0MVO31Q3QS)  
UBIDECARENONE (UNII: EJ27X76M46)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containFERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
May containFERRIC OXIDE RED (UNII: 1K09F3G675)  
May containFERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49358-584-011 in 1 CARTON07/01/2023
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/01/2023
Labeler - MDSolarSciences (013647301)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, Inc.172198223MANUFACTURE(49358-584)

Revised: 9/2023
Document Id: b5c1967b-a290-49de-bde9-c0980f1e62b9
Set id: 9ec56c68-6fea-444b-aeed-0b5d60c42e75
Version: 1
Effective Time: 20230921
 
MDSolarSciences