REVIVE INTENSITE CREME LUSTRE DAY FIRMING MOISTURE CREAM BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octisalate, and octocrylene lotion

REVIVE INTENSITE CREME LUSTRE DAY by

Drug Labeling and Warnings

REVIVE INTENSITE CREME LUSTRE DAY by is a Otc medication manufactured, distributed, or labeled by Revive Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Octocrylene 8.0%	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.

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
• 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

Other information

Protect the product in this container from excessive heat and direct sun.

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.

Questions or comments?

Call 1-866-986-7083, M – F 8am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

INTENSITÉ™
CRÈME LUSTRE DAY

RéVive

Firming Moisture Cream
Broad Spectrum SPF 30 Sunscreen

50 g /net wt. 1.7 oz.

INGREDIENTS AND APPEARANCE

REVIVE INTENSITE CREME LUSTRE DAY   FIRMING MOISTURE CREAM BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, octisalate, and octocrylene lotion

Product 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)