FACIAL WITH PLACENTA PROTEIN SPF-15- titanium dioxide oil 
BILL BEAUTY AND HEALTH PRODUCTS LTD

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.

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ACTIVE INGREDIENT

Titanium Dioxide 5%

PURPOSE

SUNSCREEN

USES

Helps prevent sunburn.

WARNINGS

If rash occurs stop use and seek medical attention. Do not use on broken or damaged skin. When using this product keep out of eyes. Rinse with water to remove. If swallowed, get medical help or contact a poison control center right away. For external use only. Keep out of reach of children.

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.

DIRECTIONS

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. For use on children less than 6 months of age, consult a health care professional. Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS

Dimethicone, Dimethicone Crosspolymer, Petrolatum, Triisostearin, Glyceryl Behenate, Tocopheryl Acetate, Aluminum Hydroxide, Stearic Acid, Aloe Barbadensis Leaf Extract, Placental Protein, Fragrance

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Placenta Oil SPF15 Drug Facts Box

FACIAL WITH PLACENTA PROTEIN  SPF-15
titanium dioxide oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70314-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
TRIISOSTEARIN (UNII: 71503RH8KG)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OVIS ARIES PLACENTA (UNII: 5OEF04MP23)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70314-201-1190 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
2NDC:70314-201-21180 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/2015
Labeler - BILL BEAUTY AND HEALTH PRODUCTS LTD (209283592)
Establishment
NameAddressID/FEIBusiness Operations
BILL BEAUTY AND HEALTH PRODUCTS LTD209283592manufacture(70314-201)

Revised: 6/2016
Document Id: decde447-5615-4c97-8c26-a323100476d0
Set id: 240d21b9-6dcf-4990-b8a2-7791246d563c
Version: 3
Effective Time: 20160606
 
BILL BEAUTY AND HEALTH PRODUCTS LTD