Label: LIP CONDITIONER SPF 15 MERLE NORMAN- octinoxate,octisalate jelly
- NDC Code(s): 57627-107-01, 57627-107-02
- Packager: Merle Norman
- 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 27, 2020
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ACTIVE INGREDIENT
Active ingredients Purpose
OCTINOXATE 7.5% Sunscreen
OCTISALATE 5.0% Sunscreen
· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.WARNINGS
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.Warnings
· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.
Directions
· Apply liberally 15 minutes before sun exposure
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months of age: Ask a doctor
Inactive
Ricinus communis ( castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera ( candelilla) wax, copernicia cerifera ( carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea ) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIP CONDITIONER SPF 15 MERLE NORMAN
octinoxate,octisalate jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE .278 g in 3.7 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE .185 g in 3.7 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) MACADAMIA OIL (UNII: 515610SU8C) CERESIN (UNII: Q1LS2UJO3A) CANDELILLA WAX (UNII: WL0328HX19) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) SHEA BUTTER (UNII: K49155WL9Y) ELAEIS GUINEENSIS FRUIT BUTTER (UNII: UYH3R74N56) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALUMINUM OXIDE (UNII: LMI26O6933) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-107-02 1 in 1 CARTON 04/21/2011 1 NDC:57627-107-01 3.7 g in 1 TUBE; 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 04/21/2011 Labeler - Merle Norman (008479388) Registrant - Merle Norman (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman 008479388 manufacture(57627-107)
