Label: BELLI PURE RADIANCE FACIAL SUNSCREEN TINTED PROTECTION SPF 25- titanium dioxide, zinc oxide cream
- NDC Code(s): 42281-003-01
- Packager: BODY HALO LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
-
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
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BELLI PURE RADIANCE FACIAL SUNSCREEN TINTED PROTECTION SPF 25
titanium dioxide, zinc oxide creamProduct 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 02/01/2022 1 44 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/22/2013 Labeler - BODY HALO LLC (080337757)
