Label: EIGHT HOUR NOURISHING LIP SPF 20- octinoxate, avobenzone emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 10967-671-61 - Packager: REVLON
- 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 February 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
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Inactive Ingredients
POLYBUTENE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PETROLATUM, RICINUS COMMUNIS (CASTOR) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15 ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC ACI, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TO DCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).
- Uses
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Warnings
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.
- Stop use and ask a doctor if rash occurs- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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Directions For Sunscreen Use
Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- 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 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-sleeve shirts, pants, hats, and sunglasses- Children under 6 months: Ask a doctor.
- CARTON ART
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INGREDIENTS AND APPEARANCE
EIGHT HOUR NOURISHING LIP SPF 20
octinoxate, avobenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-671 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) CASTOR OIL (UNII: D5340Y2I9G) NYLON-12 (UNII: 446U8J075B) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FERRIC OXIDE RED (UNII: 1K09F3G675) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) LANOLIN (UNII: 7EV65EAW6H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SHEA BUTTER (UNII: K49155WL9Y) GLYCERETH-26 (UNII: NNE56F2N14) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LINOLEIC ACID (UNII: 9KJL21T0QJ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) YELLOW WAX (UNII: 2ZA36H0S2V) HONEY (UNII: Y9H1V576FH) LINOLENIC ACID (UNII: 0RBV727H71) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PETROLATUM (UNII: 4T6H12BN9U) DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-671-61 14.2 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 10/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/21/2020 Labeler - REVLON (788820165) Registrant - REVLON (788820165) Establishment Name Address ID/FEI Business Operations Englewood Lab. INC. 080987545 manufacture(10967-671)
