BELLI ANTI-CHLOASMA FACIAL SUNSCREEN TINTED PROTECTION - titanium dioxide and zinc oxide cream 
ABT Belli-Materna Inc

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.

----------

Belli Anti-Chloasma Facial Sunscreen Tinted Protection

Active ingredient

Active ingredient                          Purpose
Titanium Dioxide (7%)...............Sunscreen
Zinc Oxide (5%)........................Sunscreen

Uses

- helps prevent sunburn  - helps SPF gives more sunburn protection

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

Keep out of reach of children. In case of accidental ingestion, contact a Poison Control Center immediately.

Directions

- smooth onto skin several times daily to protect from UV rays  - apply liberally before sun exposure and as needed  - children under 6 months of age: ask a doctor

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Butylene Glycol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ceteareth-20, Cetyl Alcohol, Cyclomethicone, Deionized Water, Glycerine, Glycereth-2 Cocoate, Glyceryl Stearate, Hydrolyzed Collagen (Marine Derived), Iodopropynyl Butylcarbamate, Iron Oxides, Isopropyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-2 Diisostearate, Octyldodecyl Neopentanoate, Sodium PCA, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Purpose

Sunscreen

Description

LETTER FROM DR. JASON RUBIN founding physician  some common skincare ingredients are absorbed into your bloodstream, where they can pass into baby's circulation.  Belli PREGNANCY is the only line that teratology screens each ingredient to guard against chemicals linked to birth defects. Every product is allergy tested, and free of artificial dyes and paraben preservatives. I created the Belli collection to help keep my wife and baby safe. Now I want to share our science with you.  jason Rubin MD  SHIELD YOURSELF FROM UVA AND UVB RAYS WITH PREGNANCY-FRIENDLY SUNSCREEN INGREDIENTS. SUN EXPOSURE DURING PREGNANCY CAN RESULT IN CHLOASMA - DARK BROWN SPOTS THAT 70% OF WOMEN EXPERIENCE.  ABOUT BELLI  Belli supports expectant and new mothers by providing soothing, balanced skincare products that pamper and protect. Our collections - Belli Pregnancy, Belli Motherhood and Belli Baby - address the specific needs of each stage, with thoughtful attention to the safest formulations.  At Belli, our love of pregnancy and motherhood guides everything we do. Our goal is to support and encourage new mothers, inspiring self-confidence and greater safety in both pregnancy and parenting.  WWW.BELLISKINCARE.COM  MANUFACTURED EXCLUSIVELY FOR BELLI MATERNA, ISSAQUAH, WA 98027  MADE IN THE USA  8  52047 00301  4  LOT  EXP.

EMBRACE LIFE ENHANCE BEAUTY  Belli  SPECIALTY SKIN CARE SOLUTIONS  Anti-Chloasma Facial Sunscreen  TINTED PROTECTION  SPF-25  ZINC OXIDE  TITANIUM DIOXIDE  #1 OB/GYN + RECOMMENDED  SHIELD YOURSELF FROM UVA AND UVB RAYS WITH PREGNANCY-FRIENDLY SUNSCREEN INGREDIENTS. SUN EXPOSURE DURING PREGNANCY CAN RESULT IN CHLOASMA - DARK BROWN SPOTS THAT 70% OF WOMEN EXPERIENCE. LIGHTWEIGHT FORMULA, OIL-FREE FOR ALL SKIN TYPES. MAY BE WORN ALONE OR UNDERNEATH MAKEUP.  DIRECTIONS: Smooth onto skin several times daily to protect from UV rays. Apply liberally before sun exposure and as needed.  WARNINGS: See outer carton.  Born 2002  2 FL. OZ./ 59 ML e  WWW.BELLISKINCARE.COM  MANUFACTURED EXCLUSIVELY FOR BELLI MATERNA, ISSAQUAH, WA 98027  MADE IN THE USA

WWW.BELLISKINCARE.COM  MANUFACTURED EXCLUSIVELY FOR BELLI MATERNA, ISSAQUAH, WA 98027  MADE IN THE USA

EMBRACE LIFE ENHANCE BEAUTY  Belli  SPECIALTY SKIN CARE SOLUTIONS  Anti-Chloasma Facial Sunscreen  TINTED PROTECTION  SPF-25  ZINC OXIDE  TITANIUM DIOXIDE  #1 OB/GYN + RECOMMENDED  Born 2002  2 FL. OZ./ 59 ML e

Product Inner Package

Inner Package

Product Outer Package 1

Outer Package 1

Product Outer Package 2

Outer Package 2

BELLI ANTI-CHLOASMA FACIAL SUNSCREEN TINTED PROTECTION 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42281-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE7 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CETYL ALCOHOL 
CYCLOMETHICONE 
WATER 
GLYCERIN 
GLYCERETH-2 COCOATE 
GLYCERYL MONOSTEARATE 
IODOPROPYNYL BUTYLCARBAMATE 
FERRIC OXIDE RED 
ISOPROPYL PALMITATE 
PEG-100 STEARATE 
PHENOXYETHANOL 
OCTYLDODECYL NEOPENTANOATE 
SODIUM PYRROLIDONE CARBOXYLATE 
ALPHA-TOCOPHEROL ACETATE 
ALPHA-TOCOPHEROL 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42281-002-001 in 1 CARTON
159 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/02/2012
Labeler - ABT Belli-Materna Inc (947134677)
Registrant - ABT Belli-Materna Inc (947134677)
Establishment
NameAddressID/FEIBusiness Operations
Chemolee Lab Corporation809982754manufacture

Revised: 1/2012
 
ABT Belli-Materna Inc