WELLCARE SUNSTICK SUNSCREEN STICK- avobenzone, octinoxate, octocrylene, octisalate stick WELLCARE SUNSTICK LIP BALM- avobenzone, octinoxate, octocrylene, octisalate stick

Wellcare Sunstick Sunscreen Stick by

Drug Labeling and Warnings

Wellcare Sunstick Sunscreen Stick by is a Otc medication manufactured, distributed, or labeled by BAMKO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

(Sunscreen Stick) Avobenzone 2.5mg  Octyl Methoxycinnamate 7.5mg  Octocrylene 10mg  OctyI Salicylate 5mg  (Lip Balm) Avobenzone 0. 5mg. Octyl Methoxycinnamate 5mg  Octocrylene 3  OctyI Salicylate 2.2mg 

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use ony.

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 righaway.

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 doctor

Other Information

Protect this product from excessive heat and direct sunlight.

Inactive Ingredients

Alpha-Tocopherol Acetate, Bis-Diglyceryl Polyacyladipate-2, Coconut Oil, Ethylhexyl Palmitate, Hydrogenated Soybean Oil, Microcrystalline Wax, Polyisobutylene(2300 MW), Olive Oil, Silicon Dioxide, Stevioside, Synthetic Wax (1200 MW).

Inactive Ingredients

Alpha-Tocopherol Acetate, Bis-Diglyceryl Polyacyladipate-2, Coconut Oil, Ethylhexyl Palmitate, Fragrance (3-(3,4-Methylenedioxyphenyl)-2-methylpropanal, Ethyl vanillin, Propylene glycol, Vanillin), Hydrogenated Soybean Oil, Microcrystalline Wax, Olive Oil, Polyisobutylene(2300 MW), Stevioside, Synthetic Wax (1200 MW).

Wellcare Sunstick - Lip Balm, 0.14oz/4g (

83149-000-00)

Wellcare Sunstick - Sunscreen Stick, 0.07oz/2g (

83149-001-00)

INGREDIENTS AND APPEARANCE

WELLCARE SUNSTICK SUNSCREEN STICK 
avobenzone, octinoxate, octocrylene, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83149-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYL VANILLIN (UNII: YC9ST449YJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VANILLIN (UNII: CHI530446X)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
STEVIOSIDE (UNII: 0YON5MXJ9P)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83149-001-00	2 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/15/2022

WELLCARE SUNSTICK LIP BALM 
avobenzone, octinoxate, octocrylene, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83149-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	22 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
OLIVE OIL (UNII: 6UYK2W1W1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEVIOSIDE (UNII: 0YON5MXJ9P)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83149-000-00	4 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/15/2022

Labeler - BAMKO, LLC (080220012)