SUN DIFFUSING PROTECTOR SPF 15 BIOELEMENTS- avobenzone, homosalate, octocrylene, octyl salicylate, oxybenzone lotion

Sun Diffusing Protector SPF 15 by

Drug Labeling and Warnings

Sun Diffusing Protector SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bioelements Inc, Bell International . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                Purpose

Avobenzone 2.0%                 Sunscreen

Homosalate 7.5%                 Sunscreen

Octocrylene 1.8 %                Sunscreen

Octyl Salicylate 5.0%            Sunscreen

Oxybenzone 0.49%              Sunscreen

PURPOSE

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply 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 measure including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeve shirts, pants, hats and sunglasses

INACTIVE INGREDIENT

Aminomethyl Propanol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Citric Acid, Citrus Aurantium (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Dimethicone, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Potassium Cetyl Phosphate, Potassium Sorbate, Salvia Officinalis (Sage) Oil, Salvia Sclarea (Clary) Oil, Sorbitol, Stearic Acid, Tetra Sodium Blutamate Diacetate Water (Aqau, Eau)

PRINCIPAL DISPLAY PANEL

Bioelements

Sun Diffusing Protector

SPF 15

Broad Spectrum

SPF 15 Sunscreen

118 mL/ 4 Fl. Oz.

INGREDIENTS AND APPEARANCE

SUN DIFFUSING PROTECTOR SPF 15  BIOELEMENTS
avobenzone, homosalate, octocrylene, octyl salicylate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.49 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SAGE OIL (UNII: U27K0H1H2O)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-120-02	1 in 1 CARTON	03/21/2012
1	NDC: 49825-120-01	118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/21/2012

Labeler - Bioelements Inc (174813923)

Registrant - Bioelements Inc (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International		967781555	manufacture(49825-120)