Label: BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-114-01, 49825-114-02 - Packager: Bioelements Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 12, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Octinoxate 7.5 % Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 3% Sunscreen
Titanium Dioxide 0.01% Sunscreen
zinc Oxide 0.01% Sunscreen
Keep out of reach of children. If swallowed get medical help or contact poison control center right away.
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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 3 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.01 mL in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.01 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-114-02 1 in 1 BOX 1 NDC:49825-114-01 177 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2009 Labeler - Bioelements Inc. (174813923) Registrant - Bioelements Inc. (174813923) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Inc. 967781555 manufacture
