BELLI PURE RADIANCE FACIAL SUNSCREEN TINTED PROTECTION SPF 25- titanium dioxide, zinc oxide cream

Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25 by

Drug Labeling and Warnings

Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25 by is a Otc medication manufactured, distributed, or labeled by BODY HALO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25

Active ingredient

Titanium Dioxide (7%)
Zinc Oxide (5%)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  

Warnings

For external use only.

When using this product

• keep out of eyes
• rinse with water to remove
  

Stop use and ask a doctor if

• rash or skin irritation develops and lasts
  

Keep out of reach of children.

In case of accidental ingestion, contact a Poison Control Center immediately.

Directions

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. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor
  

Other information

Store below 25 degree C/77 degree F.

Inactive ingredients

Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Cyclomethicone, Deionized Water, Glycereth-2 Cocoate, Glycerine, Glyceryl Stearate, Hydrolyzed Collagen (Marine Derived)  Iodopropynyl Butylcarbamate, Iron Oxides,  Isopropyl Palmitate, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-2 Diisostearate, Sodium PCA, Tocopheryl Acetate (Vitamin E), Xanthan Gum

Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25

INGREDIENTS AND APPEARANCE

BELLI PURE RADIANCE FACIAL SUNSCREEN TINTED PROTECTION SPF 25 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42281-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42281-003-01	1 in 1 CARTON
1		44 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/22/2013

Labeler - ABT Belli-Materna Inc (947134677)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(42281-003)