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

Inner Label Outer Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42281-003-01	1 in 1 CARTON	02/01/2022
1		44 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	07/22/2013

Labeler - BODY HALO LLC (080337757)

BODY HALO - Belli - Pure Radiance Facial Sunscreen Tinted Protection SPF 25 (42281-003)