Label: RAYITO DE SOL- ensulizole, sulisobenzone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 20367-133-01 - Packager: Siscom de Argentina S.A.
- 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 24, 2012
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- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- When using this product
- Stop use and ask a doctor
- Keep out of the reach of children
- Directions
- Inactive Ingredients
- Other Information
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INGREDIENTS AND APPEARANCE
RAYITO DE SOL
ensulizole, sulisobenzone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20367-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 4 g in 200 g SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE 4 g in 200 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) LAURETH-7 (UNII: Z95S6G8201) IMIDUREA (UNII: M629807ATL) PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LINALOOL, DL- (UNII: D81QY6I88E) LIMONENE, (+/-)- (UNII: 9MC3I34447) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20367-133-01 200 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/24/2012 Labeler - Siscom de Argentina S.A. (974736332)