Label: RAY DEFENSE BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-138-01, 49825-138-02, 49825-138-03, 49825-138-04 - Packager: Bioelements
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 5, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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
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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
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INGREDIENTS AND APPEARANCE
RAY DEFENSE BROAD SPECTRUM SPF 30
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone creamProduct 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)
