SPF 50 Face Sunscreen

SPF 50 Face Sunscreen

Drug Labeling and Warnings

Drug Details

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SPF 50 FACE SUNSCREEN BIOELEMENTS- avobenzone, homosalate, octinoxate, 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 Face Sunscreen

Active Ingredients                 Purpose

Avobenozone 3.0% ............. Sunscreen

Homosalate 10%   .............. Sunscreen

Octinoxate 7.0% ............... Sunscreen

Octisalate 5.0% ................ Sunscreen

Octocrylene 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Aminomethyl Propanol, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Buylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nasturtium Officinale (Watercress) Extract, Panax Ginseng (Genseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Water (Aqua, Eau)

Bioelements

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunsceen

Daily anitioxidant moisturizer

68 mL/ 2.3 Fl. Oz.

image description

SPF 50 FACE SUNSCREEN  BIOELEMENTS
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49825-201
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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
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)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49825-201-021 in 1 BOX01/04/2016
1NDC: 49825-201-0168 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/04/2016
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd017701475manufacture(49825-201)

Revised: 1/2017
 
Bioelements


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