REVIVE SENSITIF RENEWAL DAILY CELLULAR PROTECTION BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

ReVive Sensitif Renewal by

Drug Labeling and Warnings

ReVive Sensitif Renewal 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, Butylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Potassium Cetyl Phosphate, Stearic Acid, Oligopeptide-24, Polysorbate 60, Polyester-8, Sclerotium Gum, Bisabolol, Phenoxyethanol, Dimethicone, Sodium PCA, Squalane, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Allantoin, Caprylyl Glycol, Phytosterols, Chlorphenesin, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Glycolipids, Sodium Hyaluronate, Citrus Aurantium Dulcis (Orange) Oil, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Citral, Linalool, Limonene.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

SENSITIF™
RENEWAL CREAM

RéVive

Daily Cellular Protection
Broad Spectrum SPF 30 Sunscreen

50 g / net wt. 1.7 oz.

INGREDIENTS AND APPEARANCE

REVIVE SENSITIF RENEWAL   DAILY CELLULAR PROTECTION BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-419
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
LEVOMENOL (UNII: 24WE03BX2T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
OLIVE OIL (UNII: 6UYK2W1W1E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ORANGE OIL (UNII: AKN3KSD11B)
GINGER (UNII: C5529G5JPQ)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-419-50	1 in 1 CARTON	09/01/2013
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 NOT FINAL	part352	09/01/2013

Labeler - RéVive Skincare (193691821)