Label: REVIVE INTENSITE CREME LUSTRE DAY FIRMING MOISTURE CREAM BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octisalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-367-50 - Packager: Revive Skincare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 27, 2017
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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, Helianthus Annuus (Sunflower) Seed Oil, Cyclopentasiloxane, Butyloctyl Salicylate, Undecylcrylene Dimethicone, Butylene Glycol, Cetearyl Alcohol, C13-15 Alkane, Glycerin, Cyclohexasiloxane, Sorbitan Stearate, Potassium Cetyl Phosphate, PPG-2 Myristyl Ether Propionate, Tocopheryl Acetate, Palmitoyl Tripeptide-1, Decapeptide-4, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Dimethiconol, Polysorbate 60, Microcrystalline Cellulose, Polymethyl Methacrylate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Mica, Panthenol, Sodium PCA, Caprylyl Glycol, Allantoin, Chlorphenesin, Disodium EDTA, Chlorella Vulgaris Extract, Cellulose Gum, Fragrance, Carbomer, Polysorbate 20, Magnesium Ascorbyl Phosphate, Tocopherol, Lecithin, Citric Acid, Citronellol, Limonene, Linalool, Hexyl Cinnamal. May Contain (+/-): Titanium Dioxide.
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- PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
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INGREDIENTS AND APPEARANCE
REVIVE INTENSITE CREME LUSTRE DAY FIRMING MOISTURE CREAM BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-367 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 1500 mg in 50 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 2500 mg in 50 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 4000 mg in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) C13-15 ALKANE (UNII: 114P5I43UJ) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 60 (UNII: CAL22UVI4M) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) MICA (UNII: V8A1AW0880) PANTHENOL (UNII: WV9CM0O67Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALLANTOIN (UNII: 344S277G0Z) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CHLORELLA VULGARIS (UNII: RYQ4R60M02) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) POLYSORBATE 20 (UNII: 7T1F30V5YH) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) TOCOPHEROL (UNII: R0ZB2556P8) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-367-50 1 in 1 CARTON 12/01/2016 1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/01/2016 Labeler - Revive Skincare (193691821)
