RADIANT SHIELD BROAD SPECTRUM SPF 40 TINTED MINERAL SUNSCREEN- zinc oxide cream 
CosMedical Technologies, LLC

----------

Radiant Shield Broad spectrum SPF 40 Tinted Mineral Sunscreen

Drug Facts

Active Ingredient

Zinc Oxide 17%

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 occurs.

Keep out of reach of children. 

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Isododecane, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, C12-15 Alkyl Benzoate, Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Coco-Caprylate/Caprate, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Lecithin, Ectoin, Dimethylmethoxy Chromanol, Betula Alba (Birch) Bark Extract, Boswellia Serrata (Indian Frankincense) Extract, Polygonum Cuspidatum (Japanese Knotweed) Root Extract, Centella Asiatica (Gotu Kola) Extract, Butyrospermum Parkii (Shea) Butter, Glycerin, Tapioca Starch Polymethylsilsesquioxane, Propylene Carbonate, Polysilicone-11, Tromethamine, Polyglyceryl-10 Laurate, Octyldodecanol, Jojoba Esters, Trihydroxystearin, Alumina, Silica, Phenoxyethanol, Ethylhexylglycerin, Titanium Dioxide (CI 77891), Iron Oxide (CI 77491, CI 77492), Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Rose Geranium) Flower Oil.

Package Labeling:

Label

RADIANT SHIELD BROAD SPECTRUM SPF 40 TINTED MINERAL SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70060-1507
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION170 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
PROPANEDIOL (UNII: 5965N8W85T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)  
ECTOINE (UNII: 7GXZ3858RY)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
BETULA PUBESCENS BARK (UNII: 3R504894L9)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TROMETHAMINE (UNII: 023C2WHX2V)  
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70060-1507-150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/02/2024
Labeler - CosMedical Technologies, LLC (803898329)
Establishment
NameAddressID/FEIBusiness Operations
CosMedical Technologies, LLC803898329label(70060-1507)

Revised: 12/2023
Document Id: 0d947aa6-0465-d001-e063-6294a90a3657
Set id: ef75cd9d-eaf5-430e-9a80-30c50da921ff
Version: 1
Effective Time: 20231228
 
CosMedical Technologies, LLC