IMAGE SKINCARE PREVENTION PLUS DAILY DEFENSE LIP ENHANCER- zinc oxide lip sunscreen cream 
Swiss-American CDMO, LLC

----------

Image Skincare Prevention Plus Daily Defense Lip Enhancer

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 a doctor if rash occurs.  If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of Reach of Children

Keep out of Reach of Children

Active Ingredients

Zinc Oxide   11%   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.

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.

Directions For Sunscreen Use

Apply generously 15 minutes before sun exposure.  Children under 6 months of age: ask a doctor.  Reapply at least every 2 hours.  Use a water resistant sunscreen if swimming or sweating.  Immediately after towel drying.  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 Spectgrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am to 2pm, wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

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

Inactive Ingredients

hydrogenated polyisobutene, caprylic/capric triglyceride, ethylene/propylene/styrene copolymer, butyloctyl salicylate, octyldodecyl neopentanoate, pentaerythrityl tetraisostearate, isostearic acid, lecithin, polyglyceryl-3 polyricnoleate, polyhydroxystearic acid, ethylhexyl palmitate, bytlene/ethylene/styrene copolymer, aroma, tribehenin, limonene, phenyl trimethicone, ppg-12/smdi copolymer, sorbitan isostearate, silica dimethyl silylate, butylene glycol, pentylene glycol, pentaerythrityl tetra-di-t-butyl hydroxylhydrocinnamate, lacic acid, linalool, sodium chondroitin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, persea gratissma (avocado) oil, diisopropyl dimer dilinoleate, tocopheryl acetate, tocopherol, oryzanol, ubiquinone

Questions

Questions: Call 800-796-7546

Labeling

Prevention Plus

IMAGE SKINCARE PREVENTION PLUS DAILY DEFENSE LIP ENHANCER 
zinc oxide lip sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION110 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
LACTIC ACID (UNII: 33X04XA5AT)  
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ORYZANOL (UNII: SST9XCL51M)  
UBIDECARENONE (UNII: EJ27X76M46)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
CITRAL (UNII: T7EU0O9VPP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60232-0027-07 g in 1 TUBE; Type 0: Not a Combination Product01/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/02/2020
Labeler - Swiss-American CDMO, LLC (080170933)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(60232-0027)

Revised: 11/2023
Document Id: b8151402-d6f3-439b-b90a-849472a21c67
Set id: 2ba1a4fc-9877-45fa-96e4-476e070355f1
Version: 2
Effective Time: 20231106
 
Swiss-American CDMO, LLC