SUNSCREEN STICK- avobenzone, homosalate, octisalate, octocrylene stick

Sunscreen stick by

Drug Labeling and Warnings

Sunscreen stick by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredient

Avobenzone 1.5%

Homosalate 4%

Octisalate 2%

Octocrylene 4%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

Other information:

Store at 20-25 oC (68-77 oF).

Inactive ingredients:

Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN STICK 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-006-01	14 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
2	NDC: 82953-006-02	15 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
3	NDC: 82953-006-03	2 g in 1 CYLINDER; 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 - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-006)