BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream

Bioelements by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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.

PRINCIPAL DISPLAY PANEL

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula

177 mL / 6 Fl. Oz.

INGREDIENTS AND APPEARANCE

BIOELEMENTS  SUN DIFFUSING PROTECTOR SPF 15
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream

Product 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