Label: WELLCARE SUNSTICK 01- avobenzone, octyl methoxycinnamate, octocrylene, octyi salicylate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 54860-403-01 - Packager: Shenzhen Lantern Scicence Co.,Ltd.
- 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 November 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
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Inactive ingredients
Ethylhexyl Palmitate, Coconut Oil, Polyisobutylene(2300 MW), Microcrystalline Wax, Synthetic Wax(1200 MW), Hydrogenated Soybean Oil, Olive Oil, Bis-Diglyceryl Polyacyladipate-2, Silicon Dioxide, Stevioside, "3-(3,4-Methylenedioxyphenyl)-2-methylpropanal, Ethyl vanillin, Vanillin, Propylene glycol", Alpha-Tocopherol Acetate
- Directions
- When using this product
- Purpose
- Stop use and ask a doctor
- Do not use
- Other information
- use
- warnings
- Keep out of reach of children
- usage
- package
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INGREDIENTS AND APPEARANCE
WELLCARE SUNSTICK 01
avobenzone, octyl methoxycinnamate, octocrylene, octyi salicylate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-403 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 12.5 g in 200 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 7.2 g in 200 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 200 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 13 g in 200 g Inactive Ingredients Ingredient Name Strength VANILLIN (UNII: CHI530446X) 0.125 g in 200 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.125 g in 200 g ETHYL VANILLIN (UNII: YC9ST449YJ) 0.125 g in 200 g 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 0.125 g in 200 g STEVIOSIDE (UNII: 0YON5MXJ9P) 1 g in 200 g ETHYLHEXYL PALMITATE (UNII: 2865993309) 34.6 g in 200 g COCONUT OIL (UNII: Q9L0O73W7L) 33 g in 200 g POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K) 27 g in 200 g MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 20 g in 200 g SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) 18 g in 200 g HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) 16 g in 200 g OLIVE OIL (UNII: 6UYK2W1W1E) 7 g in 200 g BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) 5 g in 200 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 g in 200 g ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.2 g in 200 g Product Characteristics Color white (opaque) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-403-01 6 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2022 Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423) Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340) Establishment Name Address ID/FEI Business Operations Shenzhen Lantern Science Co.,Ltd. 421222423 manufacture(54860-403)
