FERMITIF NECK RENEWAL CREAM BROAD SPECTRUM SPF 15 SUNSCREEN US- avobenzone, octinoxate, octocrylene, oxybenzone cream

Fermitif Neck Renewal Cream Broad Spectrum SPF 15 Sunscreen US by

Drug Labeling and Warnings

Fermitif Neck Renewal Cream Broad Spectrum SPF 15 Sunscreen 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 2.0%

Octinoxate 6.0%

Octocrylene 2.7%

Oxybenzone 2.0%

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, Squalane, Cetearyl Alcohol, Butylene Glycol, Sorbitan Stearate, PPG-2 Myristyl Ether Propionate, Potassium Cetyl Phosphate, Isocetyl Stearate, Oligopeptide-20, Oligopeptide-24, Sodium Hyaluronate, Terminalia Catappa Leaf Extract, Sambucus Nigra Flower Extract, Tocopherol, Magnesium Aluminum Silicate, Tocopheryl Acetate, Bisabolol, Caprylyl Glycol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Glycolipids, Methylsilanol Hydroxyproline Aspartate, Hydrolyzed Soy Flour, Salicylic Acid, Glycerin, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Polysorbate 80, Dimethicone, Carbomer, Propylene Glycol, Aminomethyl Propanol, Sodium PCA, Parfum (Fragrance), PVP, Titanium Dioxide. Tannic Acid, Phenoxyethanol, Chlorphenesin, Disodium EDTA, Potassium Sorbate, Farnesol, Benzyl Benzoate, Citronellol, Geraniol, BHT, CI 17200 (Red 33).

Questions or comments?

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

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

FERMITIF NECK RENEWAL CREAM BROAD SPECTRUM SPF 15 SUNSCREEN US 
avobenzone, octinoxate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82691-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TERMINALIA CATAPPA LEAF (UNII: 4XBZ9J585L)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
TOCOPHEROL (UNII: R0ZB2556P8)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SALICYLIC ACID (UNII: O414PZ4LPZ)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM OLEATE (UNII: 399SL044HN)
SOYBEAN OIL (UNII: 241ATL177A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TANNIC ACID (UNII: 28F9E0DJY6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FARNESOL (UNII: EB41QIU6JL)
BENZYL BENZOATE (UNII: N863NB338G)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82691-141-00	1 in 1 CARTON	12/01/2017
1		75 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 82691-141-01	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)