FDA.reportPublic FDA data

Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:55:53

Label at a glance#

ProductNeutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Ivory to Fair 10 Sunscreen Broad Spectrum SPF30
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
Label structure13 sections

Indications and 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

Dosage and administration

For Sunscreen Use: apply liberally 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 ...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 5%, Octinoxate 7.5%, Octisalate 5%, Oxybenzone 2%, Titanium Dioxide 2.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For Sunscreen Use:

  • apply liberally 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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, phenyl trimethicone, cetyl dimethicone, butylene glycol, silica, cetearyl alcohol, glyceryl stearate, PEG 100 stearate, barium sulfate, pantothenic acid, ascorbic acid, tocopheryl acetate, retinyl palmitate, squalane, bisabolol, dipotassium glycyrrhizate, polysorbate 60, PEG-12 dimethicone, polymethyl methacrylate, polysorbate 20, magnesium aluminum silicate, cetyl hydroxyethylcellulose, tetrasodium EDTA, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate, caprylyl glycol, sorbic acid, phenoxyethanol May contain: iron oxides, mica, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Visit www.neutrogena.com or call toll-free 800-480-4812 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Ivory to Fair 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin
glow sheers ®

illuminating
tinted moisturizer

with
sunscreen

broad spectrum
SPF 30

lightweight
antioxidant blend
oil-free

ivory to fair 10
1.1 FL. OZ. (32mL)

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Ivory to Fair 10
PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Ivory to Fair 10

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Fair to Light 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin
glow sheers ®

illuminating
tinted moisturizer

with
sunscreen

broad spectrum
SPF 30

lightweight
antioxidant blend
oil-free

fair to light 20
1.1 FL. OZ. (32mL)

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Fair to Light 20
PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Fair to Light 20

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Light to Medium 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin
glow sheers ®

illuminating
tinted moisturizer

with
sunscreen

broad spectrum
SPF 30

lightweight
antioxidant blend
oil-free

light to medium 30
1.1 FL. OZ. (32mL)

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Light to Medium 30
PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Light to Medium 30

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-011669968-0116-1
69968-011569968-0115-1
69968-011469968-0114-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 99 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
BARIUM SULFATE25BB7EKE2EIACT
PANTOTHENIC ACID19F5HK2737IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SQUALANEGW89575KF9IACT
LEVOMENOL24WE03BX2TIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
POLYSORBATE 207T1F30V5YHIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
EDETATE SODIUMMP1J8420LUIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
20bbb9f2-ba14-827b-e063-6294a90a6962c6aa5386-45aa-ef0a-e053-2a95a90a6e212024-08-28WarningsExact identifier
spl id: 20bbb9f2-ba14-827b-e063-6294a90a6962
spl set id: c6aa5386-45aa-ef0a-e053-2a95a90a6e21

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.