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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Bioelements Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

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.
Sun Diffusing Protector SPF 15
Broad Spectrum UVA/UVB protection
Moisturizing Formula
177 mL / 6 Fl. Oz.
BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 8 25-114
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7.5 mL in 10 0 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
5 mL