INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN- zinc oxide cream

INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN by

Drug Labeling and Warnings

INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 13.5%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps protect against sunburn and chapped lips

WARNINGS

Do not useon damaged or broken skin

When using the productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

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

DIRECTIONS

Directions

• apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating

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

• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, Silica Dimethyl Silylate, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkiii (Shea) Butter, Tetrahexyldecyl Ascorbate, Rosa Canina Fruit Oil, Bisabolol, Sorbitan Isostearate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Dehydroxyacetic Acid, Lecithin, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Red 7 Lake (CI 15850), Tocopherol, Menthone Glycerin Acetal, Flavor.

OTHER INFORMATION

Other information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
MANGIFERA INDICA (MANGO) SEED BUTTER (UNII: 4OXD9M35X2)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
BISABOLOL (UNII: 24WE03BX2T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
TOCOPHEROL (UNII: R0ZB2556P8)
IRON OXIDES (UNII: 1K09F3G675)
MENTHONE GLYCERIN ACETAL (UNII: 7QQ1EE6RCP)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SQUALANE (UNII: GW89575KF9)
ISOSTEARIC ACID (UNII: X33R8U0062)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-192-00	1 in 1 CARTON	10/01/2024
1		17 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-192)