NDC | 14222-0425-1 |
Set ID | c7526b69-d059-499a-9134-3a1f5d0471b3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Rodan & Fields |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
-
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings For external use only
-
Directions
- Apply liberally and evenly, covering lips completely. Apply liberally 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or sweating
- 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
-
Inactive ingredients
Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinesis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecene, Dunaliella Salina Extract, Palmitoyl Tripeptide-1, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tribehenin, Sorbitan Isosterate.
- Other information
- Principal Display Panel - Essentials Lip Shield Outer Label
- Principal Display Panel - Essentials Lip Shield Primary Label
-
INGREDIENTS AND APPEARANCE
RODAN AND FIELDS ESSENTIALS LIP SHIELD BROAD SPECTRUM SPF 25
avobenzone, homosalate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-0425 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.2 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI) SHEA BUTTER (UNII: K49155WL9Y) AVOCADO OIL (UNII: 6VNO72PFC1) JOJOBA OIL (UNII: 724GKU717M) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) DUNALIELLA SALINA (UNII: F4O1DKI9A6) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TEA TREE OIL (UNII: VIF565UC2G) TRIBEHENIN (UNII: 8OC9U7TQZ0) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-0425-1 2 in 1 BOX 05/01/2017 1 4.25 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 05/01/2017 Labeler - Rodan & Fields (051659584)