REVIVE SENSITIF OIL FREE BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone and octinoxate cream

ReVive Sensitif Oil Free by

Drug Labeling and Warnings

ReVive Sensitif Oil Free 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
Octinoxate 7.5%	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, diisopropyl sebacate, butylene glycol, cyclopentasiloxane, glyceryl stearate, stearic acid, cetyl phosphate, cetearyl alcohol, sh-oligopeptide-1, phenoxyethanol, sodium PCA, polysorbate 60, aminomethyl propanol, citrus aurantium dulcis (orange) fruit extract, allantoin, methylparaben, carbomer, bisabolol, propylparaben, tocopheryl acetate, disodium EDTA, laminaria saccharina extract, glycolipids, sodium hyaluronate.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton

SENSITIF™
OIL FREE LOTION

RéVive

Broad Spectrum
SPF 15 Sunscreen

60 ml/2 fl. oz. liq. US

INGREDIENTS AND APPEARANCE

REVIVE SENSITIF OIL FREE   BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-418
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 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
NEPIDERMIN (UNII: TZK30RF92W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYSORBATE 60 (UNII: CAL22UVI4M)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ORANGE (UNII: 5EVU04N5QU)
ALLANTOIN (UNII: 344S277G0Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
LEVOMENOL (UNII: 24WE03BX2T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-418-10	1 in 1 CARTON	11/10/2014
1		60 mL in 1 BOTTLE, GLASS; 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	11/10/2014

Labeler - RéVive Skincare (193691821)