BIOELEMENTS, INC.  SPF 50 FACESCREEN- homosalate, octinoxate, octisalate, oxybenzone cream 
Bioelements, 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.

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SPF 50 FaceScreen

Active Ingredients         Purpose  

Homosalate 10%            Sunscreen

Octinoxate 7.5%            Sunscreen

Octisalate 5%               Sunscreen

Oxybenzone 6%            Sunscreen

Warnings

For external use only.

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Stop use and ask a doctor if rash and irritation develops and lasts

When using this product: keep out of eyes. Rinse with water to remove.

Uses:

for skin highly sensitive to sunburn

Directions:

Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age, ask a doctor.

Water (Aqua) (Eau), Aloe Barbadensis Leaf Juice, Glycerine, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Retinyl Palmitate, Tocopheryl Acetate, Panax Ginseng (Ginseng) Root Extract, Centella Asiatica (Gatu Kola) Extract, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Nasturtium Officinale (Watercress) Extract, Rhus Glabra (Sumac) Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Dea-cetyl Phosphate, VP/Eicosene Copolymer, Phenoxyethanol, Butylene Glycol, Triethanolamine, Carbomer, Titanium Dioxide, Glycereth-2 Cocoate, Iodopropynyl Butylcarbamate

image of carton

Bioelements

SPF 50

for Maximum UVA/UVB Protection

Antioxidant Moisturizer

73 mL/2.5 Fl. Oz.

image of primary label

BIOELEMENTS, INC.   SPF 50 FACESCREEN
homosalate, octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676)  
RHUS GLABRA BARK (UNII: 7XC0E9WP6U)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 934 (UNII: Z135WT9208)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-117-021 in 1 BOX
1NDC:49825-117-0173 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2010
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Bioelements, Inc.174813923manufacture

Revised: 1/2012
Document Id: 059a477f-0046-4d61-8b56-59ffd0c287cd
Set id: 5ec774d8-e892-42f2-b87f-8aa6b626242a
Version: 2
Effective Time: 20120117
 
Bioelements, Inc.