Label: RAY DEFENSE SPF 30 SUNSCREEN- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-121-01, 49825-121-02 - Packager: Bioelements, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 29, 2012
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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.
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)
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INGREDIENTS AND APPEARANCE
RAY DEFENSE SPF 30 SUNSCREEN
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone liquidProduct 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
