RAY DEFENSE BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Ray Defense by

Drug Labeling and Warnings

Ray Defense by is a Otc medication manufactured, distributed, or labeled by Bioelements, Cosmetic Enterprises. 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 7.0% ......... Sunscreen

Oxybenzone 5.0% ........ Sunscreen

PURPOSE

• 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

- 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

• Apply liberally 15 minutes before sun exposure
• Use a water resistan 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 INGREDIENT

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcoho, Cahmomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Phenoxyethanol, Salvia Officinalis (Sage) Oil, Salvia 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

Ray Defense

Broad Spectrum

SPF 30 Sunscreen

59 mL. / 2 Fl. OZ

INGREDIENTS AND APPEARANCE

RAY DEFENSE  BROAD SPECTRUM SPF 30
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-138
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER 940 (UNII: 4Q93RCW27E)
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)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ISOHEXADECANE (UNII: 918X1OUF1E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDIN OIL (UNII: 9RES347CKG)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-138-02	1 in 1 PACKAGE	04/27/2015
1	NDC: 49825-138-01	59 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49825-138-04	1 in 1 PACKAGE	04/27/2015
2	NDC: 49825-138-03	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	04/27/2015

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises		017701475	manufacture(49825-138)