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

Bioelements, Inc. by

Drug Labeling and Warnings

Bioelements, Inc. by is a Otc medication manufactured, distributed, or labeled by Bioelements, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Bioelements

SPF 50

for Maximum UVA/UVB Protection

Antioxidant Moisturizer

73 mL/2.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-117-02	1 in 1 BOX
1	NDC: 49825-117-01	73 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2010

Labeler - Bioelements, Inc. (174813923)

Registrant - Bioelements, Inc. (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Bioelements, Inc.		174813923	manufacture