RAY DEFENSE BORAD SPECTRUM SPF 30 SUNSCREEN BIOLEMENTS- avobenzone , octinoxate, octisalate, octocrylene, oxybenzone 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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Ray Defense SPF 30

Active ingredients            Sunscreen

Avobenzone 2.0%            Sunscreen

Octinoxate  7.5%             Sunscreen

Octisalate 5.0%               Sunscreen 

Octocrylene 7.0%            Sunscreen

Oxybenzone 5.0%           Sunscreen 

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. If product is 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 damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Directions 
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· 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 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

Allantoin, Aloe Barbdadenesis 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, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, 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).

carton

tube

label

Bioelements

Ray defense Broad Spectrum SPF 30 Sunscreen

Hydrating moisturizer to protect skin

Decreases the risk of Skin Cancer and early skin aging caused by the sun when used as directed

RAY DEFENSE BORAD SPECTRUM SPF 30 SUNSCREEN  BIOLEMENTS
avobenzone , octinoxate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARBOMER 934 (UNII: Z135WT9208)  
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 (40 CST) (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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-132-021 in 1 CARTON
1NDC:49825-132-0159 mL in 1 TUBE
2NDC:49825-132-041 in 1 CARTON
2NDC:49825-132-03118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/11/2013
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm146224444manufacture(49825-132)

Revised: 6/2013
Document Id: 5054ad1c-9909-485b-a078-0bde8f0e3981
Set id: d333a58e-742b-488e-bf69-0e3df93ce304
Version: 1
Effective Time: 20130617
 
Bioelements, Inc.