Label: SUNRIGHT BODYBLOCK SPF15- avobenzone, octinoxate, octisalate, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62839-1133-1 - Packager: NSE Products, 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 August 13, 2010
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- Active Ingredients
- Warnings
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Directions
Adults and children 6 months of age and over: Apply evenly 30 minutes before sun or water exposure. Reapply after swimming or excessive perspiring or anytime after towel drying. Children under 2 years of age: Use sunscreen products with a minimum SPF of 4. Children under 6 months of age: consult a doctor. Note: As with similar products, avoid immediate contact with natural fibers upon application.
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Inactive Ingredients
Water (Aqua), Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Aluminum Starch Octenylsuccinate, Tricontanyl PVP, Chlorella Vulgaris Extract,1 Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Stearyl Glycyrrhetinate, PEG-20 Almond Glycerides, Hydrogenated Castor Oil, Boron Nitride, Xanthan Gum, Silica Dimethyl Silylate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Stearic Acid, Carbomer, Tetrasodium EDTA, Aminomethyl Propanol, Fragrance (Parfum), Propylparaben, Phenoxyethanol, Chlorphenesin, Methylparaben, Ethylparaben, Benzyl Alcohol.
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INGREDIENTS AND APPEARANCE
SUNRIGHT BODYBLOCK SPF15
avobenzone, octinoxate, octisalate, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-1133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 g in 1000 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 g in 1000 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 30 g in 1000 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 g in 1000 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Octyldodecyl Neopentanoate (UNII: X8725R883T) Butylene Glycol (UNII: 3XUS85K0RA) Glycerin (UNII: PDC6A3C0OX) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Chlorella Vulgaris (UNII: RYQ4R60M02) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Hydrogenated Castor Oil (UNII: ZF94AP8MEY) Boron Nitride (UNII: 2U4T60A6YD) Xanthan Gum (UNII: TTV12P4NEE) Cetyl Alcohol (UNII: 936JST6JCN) Stearic Acid (UNII: 4ELV7Z65AP) Edetate Sodium (UNII: MP1J8420LU) Aminomethylpropanol (UNII: LU49E6626Q) Propylparaben (UNII: Z8IX2SC1OH) Phenoxyethanol (UNII: HIE492ZZ3T) Chlorphenesin (UNII: I670DAL4SZ) Methylparaben (UNII: A2I8C7HI9T) Ethylparaben (UNII: 14255EXE39) Benzyl Alcohol (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-1133-1 100 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2010 Labeler - NSE Products, Inc. (966817975)
