REVIVE PERFECTIF EVEN SKIN TONE DARK SPOT CORRECTOR BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

ReVive Perfectif Even Skin Tone by

Drug Labeling and Warnings

ReVive Perfectif Even Skin Tone by is a Otc medication manufactured, distributed, or labeled by RéVive Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 10.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Octocrylene 1.0%	Sunscreen
Oxybenzone 5.0%	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, 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.

Questions or comments?

Call 1-888-704-3440, M – F 8am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

PERFECTIF
EVEN SKIN TONE CREAM

RéVive

Dark Spot Corrector
Broad Spectrum SPF 30 Sunscreen

50 g / net wt. 1.7 oz.

INGREDIENTS AND APPEARANCE

REVIVE PERFECTIF EVEN SKIN TONE   DARK SPOT CORRECTOR BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product 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)