Label: SPF 15 LIP CONDITIONER- avobenzone, homosalate, octinoxate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70867-102-11, 70867-102-12, 70867-102-52 - Packager: OJAS, LLC
- 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 July 26, 2016
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
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INACTIVE INGREDIENT
Inactive Ingredients:
Simmondsia Chinensis (Jojoba) Seed Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Organic Persea Gratissima (Avocado) Oil, Dipalmitoyl Hydroxyproline, Flavor, Tetrahexyldecyl Ascorbate, Butylene/Ethylene/Styrene Copolymer, Tocopheryl Acetate, Tribehenin, Sorbitan Isostearate, Lecithin, Caprylic/Capric Triglyceride, Physalis Angulata, Extract, Leontopodium Alpinum Meristem Cell Culture, Silica Dimethyl Silylate, Polygonum Aviculare Extract, Butylene Glycol, Sodium Hyaluronate, Water, Glycerin, Palmitoyl Tripeptide-1, Citrus Aurantium Dulcis (Orange) Callus Culture Extract, Xanthan Gum.
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INGREDIENTS AND APPEARANCE
SPF 15 LIP CONDITIONER
avobenzone, homosalate, octinoxate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70867-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.0 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50.0 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50.0 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) STYRENE (UNII: 44LJ2U959V) ETHYLHEXYL PALMITATE (UNII: 2865993309) AVOCADO OIL (UNII: 6VNO72PFC1) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) 1-BUTENE (UNII: LY001N554L) ETHYLENE (UNII: 91GW059KN7) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIBEHENIN (UNII: 8OC9U7TQZ0) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWER (UNII: MWN6IZU3XM) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70867-102-11 2 mL in 1 TUBE; Type 0: Not a Combination Product 11/17/2015 2 NDC:70867-102-52 1 in 1 CARTON 11/17/2015 2 NDC:70867-102-12 7.5 mL in 1 BOTTLE, PUMP; 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 11/17/2015 Labeler - OJAS, LLC (080118329) Registrant - OJAS, LLC (080118329)
