RADIANT SHIELD BROAD SPECTRUM SPF 40 TINTED MINERAL SUNSCREEN- zinc oxide cream

Radiant Shield Broad spectrum SPF 40 Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Radiant Shield Broad spectrum SPF 40 Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by CosMedical Technologies, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

RADIANT SHIELD BROAD SPECTRUM SPF 40 TINTED MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70060-1507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	170 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70060-1507-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/02/2024

Labeler - CosMedical Technologies, LLC (803898329)

Establishment
Name	Address	ID/FEI	Business Operations
CosMedical Technologies, LLC		803898329	label(70060-1507)