LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 SUNSET SANDS- zinc oxide lipstick

LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands by

Drug Labeling and Warnings

LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 13.5%

PURPOSE

Purpose

Sunscreen

USES

Uses:

Helps prevent sunburn

WARNINGS

Warnings:

For external use only.

Do not use on damaged or broken skin.

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

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

Stop use and ask a doctor if rash occurs.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure. Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• After eating or drinking
• As often as necessary

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: DIISOSTEARYL MALATE, SILICA DIMETHYL SILYLATE, POLYBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, HYDROGENATED POLYISOBUTENE, BUTYLOCTYL SALICYLATE, MICROCRYSTALLINE WAX, BIS-DIGLYCERYL POLYACYLADIPATE-2, SORBITAN OLIVATE, ISONONYL ISONONANOATE, SORBITAN ISOSTEARATE, VP/HEXADECENE COPOLYMER, MENTHONE GLYCERIN ACETAL, DEHYDROACETIC ACID, FLAVOR, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 5 LAKE (CI 19140), RED 7 LAKE (CI 15850).

PRINCIPAL DISPLAY PANEL

Laura Geller Shine-n-Shield Lip Balm SPF 15 0.54 fl.oz./16ML

INGREDIENTS AND APPEARANCE

LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 SUNSET SANDS 
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-219
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 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
FERROUS OXIDE (UNII: G7036X8B5H)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MENTHONE GLYCERIN ACETAL (UNII: 7QQ1EE6RCP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-219-01	1 in 1 CARTON	10/01/2025
1		16 mL 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	10/01/2025

Labeler - COSMAX USA, CORP (010990210)

Registrant - COSMAX USA, CORP (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORP		010990210	manufacture(68577-219)