Label: REVIVE PERFECTIF EVEN SKIN TONE DARK SPOT CORRECTOR BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-417-40, 58411-417-50 - Packager: RéVive Skincare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 22, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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.
- Warnings
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Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
- For sunscreen use:
- Other information
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Inactive ingredients
Water, Glyceryl Stearate, Glycerin, Propanediol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Stearic Acid, Butylene Glycol, Dimethicone, Polyester-8, Polysorbate 60, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil, Oligopeptide-68, Oligopeptide-24, Phenoxyethanol, Sclerotium Gum, Phenylethyl Resorcinol, Dimethiconol, Mica, Caprylyl Glycol, Chlorphenesin, Allantoin, Sodium PCA, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Sodium Oleate, Citrus Aurantium Dulcis (Orange) Oil, Tocopherol, Citral, Limonene, Linalool. May Contain: Titanium Dioxide, Iron Oxides.
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- PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
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INGREDIENTS AND APPEARANCE
REVIVE PERFECTIF EVEN SKIN TONE DARK SPOT CORRECTOR BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-417 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SUNFLOWER OIL (UNII: 3W1JG795YI) PHENOXYETHANOL (UNII: HIE492ZZ3T) BETASIZOFIRAN (UNII: 2X51AD1X3T) PHENYLETHYL RESORCINOL (UNII: G37UFG162O) MICA (UNII: V8A1AW0880) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) ALLANTOIN (UNII: 344S277G0Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) SOYBEAN OIL (UNII: 241ATL177A) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SODIUM OLEATE (UNII: 399SL044HN) ORANGE OIL (UNII: AKN3KSD11B) TOCOPHEROL (UNII: R0ZB2556P8) CITRAL (UNII: T7EU0O9VPP) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-417-50 1 in 1 CARTON 12/01/2014 1 50 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:58411-417-40 2 g in 1 PACKET; Type 0: Not a Combination Product 12/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2014 Labeler - RéVive Skincare (193691821)
