JERGENS SKIN FIRMING NECK AND CHEST- avobenzone, octisalate, octocrylene lotion

Jergens by

Drug Labeling and Warnings

Jergens by is a Otc medication manufactured, distributed, or labeled by Kao USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Octisalate 5%

Avobenzone 1.25%

Octocrylene 1.1%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use

helps prevent sunburn

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product

• keep out of eyes.
• inse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, seek medical help.

DOSAGE & ADMINISTRATION

Directions

• apply generously and evenly 15 minutes before sun exposure
• allow time to dry before dressing
• not for use on the face
• reapply at least every 2 hours*
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor
• 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

STORAGE AND HANDLING

Other information

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

water, propylene glycol, glycerin, cetearyl alcohol, aluminum starch octenylsuccinate, niacinamide, stearic acid, tapioca starch, petrolatum, hydrogenated polydecene, dimethicone, C12-15 alkyl benzoate, ceteareth-20, glyceryl dilaurate, laureth-3, methylparaben, betaine, diethylhexyl 2,6-naphthalate, phenoxyethanol, fragrance, arginine, carbomer, PEG-12 dimethicone, sodium hydroxide, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, sodium PCA, hydrolyzed collagen, hydrolyzed elastin

QUESTIONS

Questions or comments? 1-800-742-8798

SPL UNCLASSIFIED SECTION

JERGENS is a trademaark of Kao Corp.

Questions or comments? Jergens Skincare Experts are always at your fingertips: www.jergens.com or call 1-800-742-8798.

Distributed by Kao USA Inc., Cincinnati, OH 45214

©2018 Made in USA of US & Imported ingredients

PRINCIPAL DISPLAY PANEL

ACTIVE PROTECTION WITH SPF 15

JERGENS® Skin Firming Neck & Chest

Visibly smooths, firms & protects for a more youthful appearance

RESILIENCE RECOVERY

Collagen, Elastin + Vitamin B3

REVITALIZING CREAM with Sunscreen

Broad Spectrum SPF 15

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

JERGENS  SKIN FIRMING NECK AND CHEST
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-716
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.1 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
PORK COLLAGEN (UNII: I8442U2G7J)
ARGININE (UNII: 94ZLA3W45F)
LAURETH-3 (UNII: F32E4CB0UJ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
METHYLPARABEN (UNII: A2I8C7HI9T)
NIACINAMIDE (UNII: 25X51I8RD4)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, TAPIOCA (UNII: 24SC3U704I)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
WATER (UNII: 059QF0KO0R)
BETAINE (UNII: 3SCV180C9W)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ELASTIN BOVINE (UNII: 0MT8QS774N)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
CARBOMER 980 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-716-20	1 in 1 BOX	08/01/2018
1		59 mL in 1 TUBE; 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	08/01/2018

Labeler - Kao USA Inc. (004251617)