IMAGE PREVENTION REFINER PRIMER SPF50- zinc oxide, titanium dioxide sunscreen cream

Image Prevention Refiner Primer SPF50 by

Drug Labeling and Warnings

Image Prevention Refiner Primer SPF50 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 21%   Sunscreen

Titanium Dioxide 5%   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

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. Use a water resistant sunscreen when swimming or sweating, immediately after towel drying, at least every two 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

idododecane, caprylic/capric triglyceride, butyloctyl salicylate, octyldodecyl neopentanoate, adipic acid/neopentyl glycol crosspolymer, lauryl dimethicone, polysilicone-11, propylene carbonate, silica cetyl silylate, dimethicone, stearalkonium hectorite, glycerin, polyhydroxystearic acid, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, hydrogenated polyisobutene, polyglyceryl-4 diisotearate/polyhydroxystearate/sebacate, silica, water, helinathus annuus (sunflower) seed oil, citrus aurantium dulcis (orange) peel oil, limonene, tocopheryl acetate, gossypium hirsuthum (cotton) extract, tetrahexyldecyl ascorbate, glucose, hydrolyzed pea protein, sodium chloride, glyconolactone, barosma betulina leaf oil, vanilla planifolia fruit extract, sodium benzoate, sodium succinate, calcium glyconate, iron oxides (CI77492, CI77491, CI77499)

Questions

Questions Call 800-796-7546

Labeling

INGREDIENTS AND APPEARANCE

IMAGE PREVENTION REFINER PRIMER SPF50 
zinc oxide, titanium dioxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60232-1830
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	210 g  in 1000 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ORANGE OIL (UNII: AKN3KSD11B)
GOSSYPIUM HIRSUTUM WHOLE (UNII: 0Z88765ZGC)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)
VANILLA BEAN (UNII: Q74T35078H)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	brown (tinted)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60232-1830-0	7 g in 1 TUBE; Type 0: Not a Combination Product	03/09/2020
2	NDC: 60232-1830-2	48 g in 1 TUBE; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/06/2020

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(60232-1830)