Label: RAYITO DE SOL - ensulizole and sulisobenzone gel
- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Drug Facts
- Active Ingredients
Sulisobenzone 4% Close
• helps prevent sunburnClose
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.Close
This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only
- When using this product
keep out of eyes. Rinse with water to remove.Close
- Stop use and ask a doctor
if rash occursClose
- Keep out of the reach of children
If product is swallowed, get medical help or contact a Poison Control Center right away.Close
• apply liberally 15 minutes before sun exposureClose
• after swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months: Ask a doctor
- Inactive Ingredients
ammonium acryloyldimethyltaurate/vp copolymer, d and c red no. 33, fd and c blue no. 1, fd and c yellow no. 5, glycerin, imidurea, laureth-7, limonene, (+)-, linalool, dl-, methylchloroisothiazolinone, methylisothiazolinone, parfum, phenoxyethanol, trolamine, waterClose
- Other Information
- protect this product from excessive heat and direct sun
- avoid contact with clothing to avoid staining. If staining does occur, launder within 12 hours
- Questions or Comments?
call 305.672.9486 or send an email to: email@example.comClose
- Principal Display Panel
RAYITO DE SOL
2-in-1 SPORT BRONZING
Instant Medium Color
- INGREDIENTS AND APPEARANCE
RAYITO DE SOL
ensulizole, sulisobenzone gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:20367-133 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 4 g in 200 g SULISOBENZONE (SULISOBENZONE) SULISOBENZONE 4 g in 200 g Inactive Ingredients Ingredient Name Strength Water AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER GLYCERIN TROLAMINE LAURETH-7 IMIDUREA PHENOXYETHANOL FD&C YELLOW NO. 5 D&C RED NO. 33 FD&C BLUE NO. 1 LINALOOL, DL- LIMONENE, (+/-)- METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE 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)