IMAGE SKINCARE PREVENTION PLUS DAILY DEFENSE LIP ENHANCER- zinc oxide lip sunscreen cream

Image Skincare Prevention Plus Daily Defense Lip Enhancer by

Drug Labeling and Warnings

Image Skincare Prevention Plus Daily Defense Lip Enhancer 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 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

Label

INGREDIENTS AND APPEARANCE

IMAGE SKINCARE PREVENTION PLUS DAILY DEFENSE LIP ENHANCER 
zinc oxide lip sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60232-0027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	110 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60232-0027-0	7 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2020

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(60232-0027)