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NDC 54860-0402-01 Wellcare Sunstick 3; 12.5; 7.2; 13 mg/g; mg/g; mg/g; mg/g Details

Wellcare Sunstick 3; 12.5; 7.2; 13 mg/g; mg/g; mg/g; mg/g

Wellcare Sunstick is a TOPICAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Shenzhen Lantern Scicence Co.,Ltd.. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	54860-0402
Product ID	54860-402_ed69e950-b946-158e-e053-2a95a90aca5d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Wellcare Sunstick
Proprietary Name Suffix	1
Non-Proprietary Name	Avobenzone, Octyl Methoxycinnamate, Octocrylene, OctyI Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	3; 12.5; 7.2; 13
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Shenzhen Lantern Scicence Co.,Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 54860-0402-01 (54860040201)

Pricing Information	N/A
NDC Package Code	54860-402-01
Billing NDC	54860040201
Package	6 g in 1 TUBE (54860-402-01)
Marketing Start Date	2022-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ed6a07d6-ea1f-130d-e053-2a95a90a9f67 Details

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

INGREDIENTS AND APPEARANCE

WELLCARE SUNSTICK 01

avobenzone, octyl methoxycinnamate, octocrylene, octyi salicylate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54860-402
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	12.5 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.2 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	13 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
VANILLIN (UNII: CHI530446X)	0.125 mg in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.125 mg in 1 g
ETHYL VANILLIN (UNII: YC9ST449YJ)	0.125 mg in 1 g
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)	0.125 mg in 1 g
STEVIOSIDE (UNII: 0YON5MXJ9P)	1 mg in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	34.6 mg in 1 g
COCONUT OIL (UNII: Q9L0O73W7L)	33 mg in 1 g
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)	27 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	20 mg in 1 g
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)	18 mg in 1 g
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)	16 mg in 1 g
OLIVE OIL (UNII: 6UYK2W1W1E)	7 mg in 1 g
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)	5 mg in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	2 mg in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.2 mg in 1 g

Product Characteristics
Color	white (opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54860-402-01	6 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/01/2022

Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423)

Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co.,Ltd.		421222423	manufacture(54860-402)

Revised: 11/2022

Document Id: ed69e950-b946-158e-e053-2a95a90aca5d

Set id: ed6a07d6-ea1f-130d-e053-2a95a90a9f67

Version: 1

Effective Time: 20221113