Label: RADIANCE CC SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59189-101-11 - Packager: DR. J SKINCLINIC, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 19, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
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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
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INGREDIENTS AND APPEARANCE
RADIANCE CC SPF 30
zinc oxide creamProduct 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)
