IMAGE MD RESTORING LIP ENHANCER SPF15- sunscreen cream

Image MD Restoring Lip Enhancer SPF15 by

Drug Labeling and Warnings

Image MD Restoring Lip Enhancer SPF15 by is a Otc medication manufactured, distributed, or labeled by Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. Stop use and ask doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

Avobenzone   3.0%   Sunscreen

Homosalate   10.0%   Sunscreen

Octisalate   5.0%   Sunscreen

Octocrylene   4.0%   Sunscreen

Indications & Usage

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

Keep out of reach of children

Keep out of reach of children

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

hydrogenated polyisobutene, ethylene/propylene/styrene copolymer, Pentaerythrityl Tetraisostearate, ethylhexyl palmitate, PPG-12/SMDI Copolymer, butylene/ethylene/styrene copolymer, flavor, limonene, tribehenin, phenyl trimethicone, sorbitan isostearate, silican dimethyl silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, butylene glycol, pentylene glycol, lactic acid, linalool, sodium chondrotin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, Avacodo (Persea gratissima) Oil, Diisopropyl Dimer Dilinoleate, Tocopheryl Acetate, Tocopherol, Oryzanol, Ubiquinone.

Questions

Questions call 800-796-7546

Labeling

INGREDIENTS AND APPEARANCE

IMAGE MD RESTORING LIP ENHANCER SPF15 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60232-3537
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 g  in 1000 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 g  in 1000 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 g  in 1000 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID (UNII: 33X04XA5AT)
LINALOOL, (+)- (UNII: F4VNO44C09)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
CITRAL (UNII: T7EU0O9VPP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
ORYZANOL (UNII: SST9XCL51M)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60232-3537-0	15 g in 1 TUBE; Type 0: Not a Combination Product	03/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/17/2022

Labeler - Swiss-American CDMO, LLC (080170933)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(60232-3537)