RAY DEFENSE SPF 30 SUNSCREEN- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone liquid

Ray Defense by

Drug Labeling and Warnings

Ray Defense by is a Otc medication manufactured, distributed, or labeled by Bioelements, Inc. , Neutraderm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients               Purpose

Avobenzone 2.0 %              Sunscreen

Octinoxate 7.5 %                Sunscreen

Octisalate 5.0 %                 Sunscreen

Octocrylene 7.5 %               Sunscreen

Oxybenzone 5.0%                Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measure (see Direction) decreases the risk of skin cancer and early skin aging caused by the sun.

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

Stop use and ask a doctor if rash occurs

Warnings

For external Use only
Do not use on broken skin.
When using this product keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least 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 measures including:

limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane, Dimethicone, Dimethiconol, Ehtylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phophate, Salvia Officinalis (Sage) Oil, Salvea Sclarea (Clary Oil), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA,Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau)

PRINCIPAL DISPLAY PANEL

Bioelements

Ray Defense SPF 30

Broad Spectrum SPF 30 Sunscreen

Moisturizes and decreases the risk of early skin aging caused by the sun when used as directed.

118 mL / 4 Fl.Oz.

INGREDIENTS AND APPEARANCE

RAY DEFENSE  SPF 30 SUNSCREEN
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ISOHEXADECANE (UNII: 918X1OUF1E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SAGE OIL (UNII: U27K0H1H2O)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE SODIUM (UNII: MP1J8420LU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-121-02	1 in 1 CARTON
1	NDC: 49825-121-01	118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/23/2012

Labeler - Bioelements, Inc. (174813923)

Registrant - Bioelements, Inc. (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm		146224444	manufacture