Label: IMAGE PREVENTION REFINER PRIMER SPF50- zinc oxide, titanium dioxide sunscreen cream
- NDC Code(s): 60232-1830-0, 60232-1830-2
- Packager: Swiss-American CDMO, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Warnings
- Keep out of Reach of Children
- Active Ingredients
- Uses
- Uses
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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
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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
- Labeling
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INGREDIENTS AND APPEARANCE
IMAGE PREVENTION REFINER PRIMER SPF50
zinc oxide, titanium dioxide sunscreen creamProduct 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 Drug M020 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)
