RADIANCE CC SPF 30- zinc oxide cream

RADIANCE CC by

Drug Labeling and Warnings

RADIANCE CC by is a Otc medication manufactured, distributed, or labeled by DR. J SKINCLINIC, INC., MICRO CONNECTION ENTERPRISES, INC., THE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RADIANCE CC  SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59189-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59189-101-11	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/02/2019

Labeler - DR. J SKINCLINIC, INC. (101497332)

Establishment
Name	Address	ID/FEI	Business Operations
MICRO CONNECTION ENTERPRISES, INC., THE		144297160	pack(59189-101)

Establishment
Name	Address	ID/FEI	Business Operations
DR. J SKINCLINIC, INC.		101497332	manufacture(59189-101)