Label: SPF 30 TROPICAL FLAVOR SUNSCREEN LIP BALM ULTA- avobenzone 2.00% octisalate 3.00% octocrylene 7.00% oxybenzone 3.00% stick
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Contains inactivated NDC Code(s)
NDC Code(s): 62296-7780-1 - Packager: Ulta
- 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 October 12, 2017
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 2.00%........................................................................Sunscreen
Octisalate 3.00%............................................................................Sunscreen
Octocrylene 7.00%.........................................................................Sunscreen
Oxybenzone 3.00%........................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water to remove.
• Keep away from face to avoid breathing it • Do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
Stop use and ask a doctor if rash occurs - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 TROPICAL FLAVOR SUNSCREEN LIP BALM ULTA
avobenzone 2.00% octisalate 3.00% octocrylene 7.00% oxybenzone 3.00% stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62296-7780 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 2 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 3 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 7 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 3 g in 100 g Inactive Ingredients Ingredient Name Strength ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) ALOE (UNII: V5VD430YW9) Ascorbic Acid (UNII: PQ6CK8PD0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Cetyl Alcohol (UNII: 936JST6JCN) PUMMELO (UNII: ET1TN5W71X) LEMON PEEL (UNII: 72O054U628) CUCUMBER (UNII: YY7C30VXJT) Diisobutyl Adipate (UNII: 8OPY05ZY7S) Dimethicone (UNII: 92RU3N3Y1O) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) Ethylhexyl Palmitate (UNII: 2865993309) GINKGO (UNII: 19FUJ2C58T) Hydrated Silica (UNII: Y6O7T4G8P9) Isostearyl Linoleate (UNII: 4778M3HR0N) CERESIN (UNII: Q1LS2UJO3A) ASIAN GINSENG (UNII: CUQ3A77YXI) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Polysorbate 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ROSEMARY (UNII: IJ67X351P9) SALIX ALBA BARK (UNII: 205MXS71H7) SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL) SACCHARIN SODIUM (UNII: SB8ZUX40TY) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Trisiloxane (UNII: 9G1ZW13R0G) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62296-7780-1 0.14 g in 1 TUBE; Type 0: Not a Combination Product 01/27/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/27/2016 Labeler - Ulta (608168597) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(62296-7780) , label(62296-7780)
