RADIANCE CC SPF 30- zinc oxide cream 
DR. J SKINCLINIC, INC.

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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California Pure Naturals - Radiance CC Cream SPF 30

ACTIVE INGREDIENT

Non-Nano Uncoated
Zinc Oxide (13%)

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

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 or irritation occurs.

Keep out of reach of children:

If swallowed, get medical help or contact Poison Control Center immediately.

DIRECTIONS:

Shake well for several seconds, then apply liberally over the face and neck 15 minutes prior to sun exposure.

INACTIVE INGREDIENTS:

*(Decolorized) Aloe Barbadensis (Aloe Vera) Leaf Juice, *Rubus Ursinus (California Blackberry) Fruit, *Actinidia Chinensis (California Kiwi) Fruit, *Punica Granatum (California Pomegranate) Fruit, *Vitis Vinifera (California Grapes) Fruit, *Simmondsia Chinensis (Jojoba) Seed Oil, *Argania Spinosa (Argan) Kernel Oil, *Borago Officinalis (Borage) Seed Oil, *Vaccinium Macrocarpon (Cranberry) Seed Oil, *Rosa Canina (Rosehip) Fruit Oil, Tocopherol, *Rubus Idaeus (Raspberry) Seed Oil, *Carthamus Tinctorius (Safflower) Seed Oil, *Cocos Nucifera (Coconut) Oil, Glycerin, CI 77492,CI 77491, CI 77499, CI 77891, *Tapioca Starch, Silica, Benzyl Alcohol,Glyceryl Caprylate, Glyceryl Undecylenate, Sodium Benzoate, Potassium Sorbate, Limonene, Linalool, Fragrance (Natural Parfum)

*organic

Dermatology tested.

CC Cream SPF-30

RADIANCE CC  SPF 30
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59189-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
RUBUS URSINUS WHOLE (UNII: EB3AN7DKSL)  
KIWI FRUIT (UNII: 71ES77LGJC)  
POMEGRANATE JUICE (UNII: 99S671U9KB)  
GRAPE (UNII: 6X543N684K)  
JOJOBA OIL (UNII: 724GKU717M)  
ARGAN OIL (UNII: 4V59G5UW9X)  
BORAGE OIL (UNII: F8XAG1755S)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59189-101-1150 mL in 1 TUBE; Type 0: Not a Combination Product02/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/02/2019
Labeler - DR. J SKINCLINIC, INC. (101497332)
Establishment
NameAddressID/FEIBusiness Operations
MICRO CONNECTION ENTERPRISES, INC., THE144297160pack(59189-101)
Establishment
NameAddressID/FEIBusiness Operations
DR. J SKINCLINIC, INC.101497332manufacture(59189-101)

Revised: 2/2019
Document Id: 1152ce21-8d97-4926-9046-38e4b7a5c1c3
Set id: 8ad70ab9-2f77-46df-9882-d502cb6422d7
Version: 4
Effective Time: 20190219
 
DR. J SKINCLINIC, INC.