Label: TIEGE HANLEY MOISTURIZING LIP BALM SPF 30- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-1004-1 - Packager: Raining Rose, Inc.
- 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 April 13, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients Pentaerythrityl Tetraisostearate, Oryza Sativa (Rice) Bran Wax, Prunus Amygdalus Dulcis
(Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Glyceryl Stearate, Squalene, Behenyl
Alcohol, Moringa Oleifera Seed Oil, Caprylic/Capric Triglyceride, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia
Chinensis (Jojoba) Seed Oil, Citrus Reticulata Blanco (Tangerine) Oil, Polyhydroxystearic Acid, Undaria Pinnatifida
Extract, Mentha Piperita (Peppermint) Oil - Package Labeling
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INGREDIENTS AND APPEARANCE
TIEGE HANLEY MOISTURIZING LIP BALM SPF 30
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-1004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 75 mg in 1 g Inactive Ingredients Ingredient Name Strength PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) RICE BRAN (UNII: R60QEP13IC) ALMOND OIL (UNII: 66YXD4DKO9) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SQUALENE (UNII: 7QWM220FJH) DOCOSANOL (UNII: 9G1OE216XY) MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) JOJOBA OIL (UNII: 724GKU717M) MANDARIN OIL (UNII: NJO720F72R) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-1004-1 1 in 1 PACKAGE 04/01/2020 1 4.2 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 final part352 03/28/2020 Labeler - Raining Rose, Inc. (083819404) Registrant - Raining Rose, Inc. (083819404) Establishment Name Address ID/FEI Business Operations Raining Rose, Inc. 083819404 manufacture(65692-1004) , label(65692-1004) , pack(65692-1004)