RADIANT GLOW ILLUMINATING BB CREAM SUNSCREEN SPF 30 - TAN- octinoxate, titanium dioxide, zinc oxide cream

Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan by

Drug Labeling and Warnings

Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan by is a Otc medication manufactured, distributed, or labeled by Pur-lisse Beauty, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 6.5%

Titanium Dioxide 6.64%

Zinc Oxide 3.5%

Purpose

Sunscreen

Uses

Use helps prevent sunburn

Warnings

For external use only

Do not use on damage 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

For sunscreen use:

• Apply liberally 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. to 2 p.m.
• Wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun light.

Inactive Ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, 1,2-Hexanediol, Sorbitan Sesquioleate, Mica, Alumina, Disteardimonium Hectorite, Synthetic Beeswax, Sodium Chloride, Ceresin, Dimethicone, Polyglyceryl-4 Isostearate, Hexyl Laurate, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Tin Oxide, Tocopherol, Schisandra Chinensis Fruit Extract, Lycium Chinense Fruit Extract, Cornus Officinalis Fruit Extract, Crataegus Oxyacantha Fruit Extract, Bacillus Ferment, Gardenia Jasminoides Fruit Extract, Iron Oxides (CI 77492, CI 77491, CI 77499)

Questions or comments?

Visit www.purlisse.com.

Principal Display Panel – Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan

pūrlisse

Radiant Glow

ILLUMINATING

BB

CREAM

SUNSCREEN

SPF 30

oil free

moisturizing

natural-looking coverage

illuminated finish

for normal – dry skin

even sensitive

1.4 fl. oz. / 40 mL

INGREDIENTS AND APPEARANCE

RADIANT GLOW ILLUMINATING BB CREAM SUNSCREEN SPF 30 - TAN 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72407-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.64 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINA (UNII: LMI26O6933)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CRATAEGUS LAEVIGATA FRUIT (UNII: D5RZ7MF1YF)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
BACILLUS POLYFERMENTICUS (UNII: 6UQO3086C7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CERESIN (UNII: Q1LS2UJO3A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERROUS OXIDE (UNII: G7036X8B5H)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
TIN OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72407-439-40	1 in 1 CARTON	12/28/2022
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/28/2022

Labeler - Pur-lisse Beauty, LLC (052040103)