BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide 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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Sun Diffusing Protector SPF 15

Active Ingredients                           Purpose

Octinoxate 7.5 %                           Sunscreen

Octisalate 5%                                Sunscreen

Oxybenzone 3%                            Sunscreen

Titanium Dioxide 0.01%                  Sunscreen

zinc Oxide 0.01%                           Sunscreen

Uses

For skin highly sensitive to sunburn

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

Warnings

For external use only.

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


Directions

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


Inactive Ingredients
Water (aqua) (eau), sorbitol, c12-15 alkyl benzoate, DEA cetyl phosphate, stearic acid, cetyl alcohol, dimethicone, carbomer, Lavendula Augustifolia (Lavender) oil, Salvia Officinalis (sage) Oil, Salvia sclarea (clary sage) oil, Citrus aurantium (petitgrain cordillera) oil, Citrus Aurantium (neroli) oil, Lavendula Hybridia (Lavendin) Oil, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine.




image of carton label

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula

177 mL / 6 Fl. Oz.


image of front label

BIOELEMENTS  SUN DIFFUSING PROTECTOR SPF 15
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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) OXYBENZONE3 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.01 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SAGE OIL (UNII: U27K0H1H2O)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-114-021 in 1 BOX
1NDC:49825-114-01177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2009
Labeler - Bioelements Inc. (174813923)
Registrant - Bioelements Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories, Inc.967781555manufacture

Revised: 1/2012
Document Id: 19d7afa4-cd7c-4876-91f7-cf916fa73748
Set id: 6550938a-7299-4e4b-aafe-4d5ce13e79a5
Version: 6
Effective Time: 20120112
 
Bioelements Inc.