NDC | 49825-070-01 |
Set ID | bdc10f9f-7e90-4794-b813-773f483a655c |
Category | HUMAN OTC DRUG LABEL |
Packager | CHROMAVIS SPA |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- PURPOSE
- WARNINGS
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Other Ingredients
Hydrogenated polyisobutene, Cera microcristallina (Microcrystalline wax), Caprylic/Capric Triglyceride, Tridecyl Trimellitate, Polybutene, Polyethylene, Ricinus Communis oil (ricinus communis (castor) seed oil), Diisostearyl Malate, Butyrospermum Parkii butter (Butyrospermum parkii (shea Butter), Ethylhexyl palmitate,Oryzanol, Tocopheryl acetate,Tribehenin, Prunus armeniaca kernel oil (prunus armeniaca (apricot) kernel oil), Dimethicone, Cyclomethicone, Sorbitan isostearate, Ethylene/VA Copolymer, Isododecane, BHT, Lactic acid, Palmitoyl Oligopeptide, Propylparaben, Methylparaben, Aroma (Flavor)
May Contain: Mica, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxide)
Refer to the Package Label
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FORME COSMETICS DELICIOUS LIP BALM SPF 12
titanium dioxide, octinoxate, avobenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.04128 g in 3.2 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.048 g in 3.2 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.192 g in 3.2 g Inactive Ingredients Ingredient Name Strength Lactic Acid (UNII: 33X04XA5AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-070-01 3.2 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/22/2009 Labeler - CHROMAVIS SPA (338561621) Establishment Name Address ID/FEI Business Operations CHROMAVIS SPA 338561621 manufacture