Label: CICATRICURE BRIGHTENING FACE WITH SPF- avobenzone, homosalate, octinoxate, octisalate, and oxybenzone cream
- NDC Code(s): 50066-704-01
- Packager: Genomma Lab USA
- 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 February 7, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use
- apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating.
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 factor of 15 or higher and other skin protection measures including:
- limit time in the sun, especially from 10am to 2pm
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
WATER, GLYCERIN, ALCOHOL, POLYSORBATE 60, SORBITAN STEARATE, BUTYLENE GLYCOL, TRIETHANOLAMINE, CARBOMER, BENZYL ALCOHOL, PHENOXYETHANOL, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, FRAGRANCE, POLYSORBATE 20, HYDROLYZED OAT PROTEIN, PPG-2 MYRISTYL ETHER PROPIONATE, ETHYL ASCORBIC ACID, ALPHA-ARBUTIN, ETHYLHEXYLGLYCERIN, SILANEDIOL SALICYLATE, MELANIN, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7.
- Questions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CICATRICURE BRIGHTENING FACE WITH SPF
avobenzone, homosalate, octinoxate, octisalate, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-704 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 10 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 45 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 45 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength glycerin (UNII: PDC6A3C0OX) Polysorbate 60 (UNII: CAL22UVI4M) Polysorbate 20 (UNII: 7T1F30V5YH) Sorbitan Monostearate (UNII: NVZ4I0H58X) Butylene glycol (UNII: 3XUS85K0RA) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-704-01 1 in 1 CARTON 10/07/2019 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/07/2019 Labeler - Genomma Lab USA (832323534)