Label: LIP BALM MINT CVS- avobenzone 2.00% homosalate 15.00% octisalate 5.00% octinoxate 7.50% stick
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-033-01 - Packager: CVS
- 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, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- INDICATIONS & USAGE
- WarningsFor external use only
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Directions
• apply liberally 15 minutes before sun exposure
• reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
• 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 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
• children under 6 month: Ask a doctor -
Inactive ingredients
Ascorbyl Palmitate, Beeswax, Benzyl Alcohol, BHT, Candelilla Wax, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Persea , Gratissima (Avocado) Oil, Polyester-8, Retinyl Palmitate, Ricinus Communis (Castor) Seed Oil, Saccharin, Simmondsia Chinensis (Jojoba) , Seed Oil, Tocopheryl Acetate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIP BALM MINT CVS
avobenzone 2.00% homosalate 15.00% octisalate 5.00% octinoxate 7.50% stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-033 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 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 in 100 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength Ascorbyl Palmitate (UNII: QN83US2B0N) YELLOW WAX (UNII: 2ZA36H0S2V) Benzyl Alcohol (UNII: LKG8494WBH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Candelilla Wax (UNII: WL0328HX19) Ethylhexyl Palmitate (UNII: 2865993309) SUNFLOWER OIL (UNII: 3W1JG795YI) AVOCADO OIL (UNII: 6VNO72PFC1) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CASTOR OIL (UNII: D5340Y2I9G) Saccharin (UNII: FST467XS7D) JOJOBA OIL (UNII: 724GKU717M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-033-01 1 in 1 CARTON 12/18/2014 1 4 g in 1 CONTAINER; 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 12/18/2014 Labeler - CVS (062312574) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(69842-033) , label(69842-033)