SPF15 LIP BALM 01- octocrylene, octisalate lipstick

SPF15 lip balm by

Drug Labeling and Warnings

SPF15 lip balm 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 Ingredients

Octocrylene 2%

Octisalate 2%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection

warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours
• Children under 6 months: ask a doctor
• Sun protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10a.m.- 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

Other information

Protect from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF15 LIP BALM  01
octocrylene, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-009
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CERESIN (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-009-01	2.2 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
2	NDC: 82953-009-02	4.5 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
3	NDC: 82953-009-03	5 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
4	NDC: 82953-009-04	5.5 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
5	NDC: 82953-009-05	6.5 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
6	NDC: 82953-009-06	7 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
7	NDC: 82953-009-07	10 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
8	NDC: 82953-009-08	12 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
9	NDC: 82953-009-09	2 g in 1 CYLINDER; Type 0: Not a Combination Product	10/01/2022
10	NDC: 82953-009-10	0.9 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(82953-009)