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)

Label

Wellcare Sunstick - Sunscreen Stick, 0.07oz/2g (83149-001-00)

P1L

P2L

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
.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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
.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)

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

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

Labeler - BAMKO, LLC (080220012)