BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS- avobenzone, homosalate, ocinoxate, octisalate, octocrylene, oxybenzone cream 
Bioelements

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

Avobenzone 3.0%              Sunscreen
Homosalate 10%                Sunscreen

Octinoxate 7.0%                 Sunscreen

Octisalate 5.0%                  Sunscreen

Oxybenzone 6.0%              Sunscreen

Uses
· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Directions
· 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

· 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice powder, Angelica  Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua, Eau)

secondary

jar

Bioelements

Used in Professional Facials

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunscreen

Daily antioxidant moisturizer

Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed

68 mL/ 2.3 Fl. Oz.

BROAD SPECTRUM SPF 50 SUNSCREEN  BIOELEMENTS
avobenzone, homosalate, ocinoxate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
CHAMOMILE (UNII: FGL3685T2X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
RHUS GLABRA BARK (UNII: 7XC0E9WP6U)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-133-021 in 1 BOX
1NDC:49825-133-0168 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/11/2013
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises017701475manufacture(49825-133)

Revised: 12/2014
Document Id: 511ea5f5-7cbd-495f-b252-fbe14ae0bf7c
Set id: 51259d41-610c-4372-91ba-2f4c02e9b42d
Version: 5
Effective Time: 20141218
 
Bioelements