NEUTROGENA ULTRA GENTLE DAILY FACIAL MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (2.5%), Homosalate (8%), Octisalate (5%), Octocrylene (8%)

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 useon damaged or broken skin

• When using this productkeep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor ifrash 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 generously and evenly 15 minutes before sun exposure

• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
  • 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 this product from excessive heat and direct sun
• may stain some fabrics
• Do not use if quality seal is broken or missing

Inactive ingredients

Water, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Ethylhexylglycerin, Centella Asiatica Extract, Bisabolol, Caprylyl Glycol, Butylene Glycol, Dimethicone, Steareth-100, Steareth-2, Xanthan Gum, Mannan, Aluminum Starch Octenylsuccinate, Ethylhexyl Stearate, Trideceth-6, Neopentyl Glycol Diheptanoate, Polyester-7, Sodium Polyacrylate, Acrylates/Dimethicone Copolymer, Disodium EDTA, BHT, Phenoxyethanol, Chlorphenesin

Questions?

800-582-4048;Outside US, dial collect 215-273-8755. neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - .05 FL

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

SPF

30

ULTRA

GENTLE

Daily Facial

Moisturizer

Sunscreen

Broad Spectrum SPF 30

Normal to Sensitive Skin

Lightweight, strengthens

skin’s moisture barrier

in 1 use

with CICA

.05 FL

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA GENTLE DAILY FACIAL MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52328-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARETH-2 (UNII: V56DFE46J5)
POLYESTER-7 (UNII: 0841698D2F)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARETH-100 (UNII: 4OH5W9UM87)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BHT (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MANNAN (UNII: 91R887N59P)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52328-310-01	1 mL in 1 POUCH; Type 0: Not a Combination Product	06/06/2024
2	NDC: 52328-310-02	24 in 1 TRAY	06/06/2024
2		1.4 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/06/2024

Labeler - Acupac Packaging, Inc. (037138013)

Registrant - Acupac Packaging, Inc. (037138013)