IMAGE SKINCARE PREVENTION PLUS DAILY ULTIMATE PROTECTION- homosalate, octisalate, octocrylene, zinc oxide sunscreen cream

Image Skincare Prevention Plus Daily Ultimate Protection by

Drug Labeling and Warnings

Image Skincare Prevention Plus Daily Ultimate Protection 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

Homosalate   10.0%   Sunscreen

Octisalate   5.0%   Sunscreen

Octocrylene   6.0%   Sunscreen

Zinc Oxide   9.0%   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 Spectrum 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

water, caprylic/capric triglyceride, glycerin, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, thermus thermophillus ferment, polyacrylate-13, cetearyl ethylhexanoate, phenoxyethanol, polyisobutene, polyglyceryl-6 polyricinoleate, lecithin, isostearic acid, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, soidum chloride, cetearyl dimethicone, marrubium vulgare extract, helianthus annus (sunflower) see oil, disteardimonium hectorite, polysorbate 20, citrus aurantum dulcis (orange) peel oil, limonene, sorbitan isostearate, ethylhexylglycerin, panthenol, citrus nobils (mandarin orange) peel oil, disodium EDTA, sodium hyaluronate, melanin, erythritol, citric acid, vanilla planifolia fruit extract, glycose, potassium sorbate, hydrolyzed pea protein, tocopherol, PEG-8/SMDI copolymer, tetrahexyldecyl ascoorbate, tocopheryl acetate, barosma betuuna (buchu) leaf oil, soidum benzoate, homarine HCL, pentaerythrityl tetra-di-t-butylhydroxyhydrocinnamate, sodium succinate, mallis domestica fruit cell culture extract, arabidopsis thaliana (thale cress) extract, micrococcus lysate, plankton extract, ergothioneine

Questions

Call 800-796-7546

Label

INGREDIENTS AND APPEARANCE

IMAGE SKINCARE PREVENTION PLUS DAILY ULTIMATE PROTECTION 
homosalate, octisalate, octocrylene, zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60232-1022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 g  in 1000 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 g  in 1000 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	90 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONIC ACID (UNII: S270N0TRQY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ERYTHRITOL (UNII: RA96B954X6)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
MARRUBIUM VULGARE (UNII: 7A72MUN24Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
.DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ORANGE OIL (UNII: AKN3KSD11B)
VANILLA BEAN (UNII: Q74T35078H)
AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60232-1022-0	7 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2020
2	NDC: 60232-1022-3	91 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2020

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(60232-1022)