Label: TONYMOLY MAGIC FOOD MANGO MILD SUN BLOCK- octinoxate, octisalate, avobenzone, ensulizole, homosalate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 59078-210-01 - Packager: TONYMOLY CO.,LTD
- 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 January 20, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive ingredients: Water, Butylene Glycol, Alcohol Denat., Octocrylene, Phenethyl Benzoate, Aminomethyl Propanol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Triceteareth-4 Phosphate, Glycol Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, PEG-2 Stearate, Fragrance(Parfum), Phenoxyethanol, Glyceryl Caprylate, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Disodium EDTA, Citrus Limon (Lemon) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Propylene Glycol, 1,2-Hexanediol, Citrus Aurantium Dulcis (Orange) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Psidium Guajava Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ethylhexylglycerin
- PURPOSE
- WARNINGS
-
DESCRIPTION
Uses: - helps prevent sunburn - If used as directed with other sun protection measures
Directions: decreases the risk of skin cancer and early skin aging caused by the sun
Directions:
For sunscreen use: - apply liberally 15 minutes before sun exposure - use a water resistant sunscreen if swimming or sweating - reapply 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 with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses - children under 6 months: Ask a doctor
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TONYMOLY MAGIC FOOD MANGO MILD SUN BLOCK
octinoxate, octisalate, avobenzone, ensulizole, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.10 g in 45 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.02 g in 45 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.57 g in 45 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.57 g in 45 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1.35 g in 45 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-210-01 45 g in 1 CARTON; 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 12/01/2015 Labeler - TONYMOLY CO.,LTD (688216798) Registrant - TONYMOLY CO.,LTD (688216798) Establishment Name Address ID/FEI Business Operations TONYMOLY CO.,LTD 688216798 manufacture(59078-210)