INTENSITE CREME LUSTRE DAY SPF 30 US- avobenzone, octisalate, octocrylene cream

Intensite Creme Lustre Day SPF 30 US by

Drug Labeling and Warnings

Intensite Creme Lustre Day SPF 30 US by is a Otc medication manufactured, distributed, or labeled by RV Skincare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octocrylene 8.0%

Purpose

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 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






Sun Protection Measures.

Other information

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

Inactive ingredients:

Aqua (Water, Eau), Helianthus Annuus (Sunflower) Seed Oil, Cyclopentasiloxane, Undecylcrylene Dimethicone, Butyloctyl Salicylate, Butylene Glycol, Cetearyl Alcohol, C13-15 Alkane, Glycerin, Sorbitan Stearate, PPG-2 Myristyl Ether Propionate, Potassium Cetyl Phosphate, Oligopeptide-20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Tocopheryl Acetate, Panthenol, Allantoin, Magnesium Ascorbyl Phosphate, Tocopherol, Chlorella Vulgaris Extract, Caprylyl Glycol, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Phosphatidylcholine, Cellulose Gum, Sodium Lactate, Mica, Dimethiconol, Lecithin, Polymethyl Methacrylate, Microcrystalline Cellulose, Aminomethyl Propanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 60, Parfum (Fragrance), Carbomer, Polysorbate 20, Sodium PCA, Phenoxyethanol, Citric Acid, Chlorphenesin, Disodium EDTA, Cyclohexasiloxane, Linalool, Citronellol, Limonene, Hexyl Cinnamal, CI 77891 (Titanium Dioxide).

Questions or comments?

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

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

INTENSITE CREME LUSTRE DAY SPF 30 US 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82691-142
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
C13-15 ALKANE (UNII: 114P5I43UJ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TOCOPHEROL (UNII: R0ZB2556P8)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM OLEATE (UNII: 399SL044HN)
SOYBEAN OIL (UNII: 241ATL177A)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM LACTATE (UNII: TU7HW0W0QT)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82691-142-00	1 in 1 CARTON	12/01/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 82691-142-01	5 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2017

Labeler - RV Skincare LLC (080986653)