WELLCARE SUNSTICK 01- avobenzone, octyl methoxycinnamate, octocrylene, octyi salicylate paste 
Shenzhen Lantern Scicence Co.,Ltd.

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.

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Wellcare Sunstick

Drug Facts

drug facts

Active Ingredient

(Sunscreen Stick)
Avobenzone 2.5mg Sunscreen
Octyl Methoxycinnamate 7.5mg Sunscreen
Octocrylene 10mg Sunscreen
OctyI Salicylate 5mg Sunscreen

(Lip Balm)
Avobenzone 0. 5mg.
Octyl Methoxycinnamate 5mg Sunscreen
Octocrylene 3 Sunscreen
OctyI Salicylate 2.2mg Sunscreen

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

Apply liberally 15 minutes before sunexposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months: Ask a docto

When using this product

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center rightaway

Purpose

Sunscreen

Stop use and ask a doctor

if rash occurs.

Do not use

On damaged or broken skin.
When using this product keep out of eyes.
Rinse with water to remove

Other information

Protect this product from excessive heat and direct sunlight

use

Helps prevent sunburn.

warnings

For external use only.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center rightaway.

usage

Apply liberally 15 minutes before sunexposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months: Ask a docto

package

package lable

WELLCARE SUNSTICK  01
avobenzone, octyl methoxycinnamate, octocrylene, octyi salicylate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE12.5 g  in 200 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.2 g  in 200 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 200 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE13 g  in 200 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54860-403-016 g in 1 TUBE; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2022
Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)
Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-403)

Revised: 11/2022
Document Id: edf2f110-9fa0-7c1c-e053-2995a90a7db6
Set id: edf2f110-9f9f-7c1c-e053-2995a90a7db6
Version: 2
Effective Time: 20221120
 
Shenzhen Lantern Scicence Co.,Ltd.