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Neutrogena Boost Your Skins Vitals Team Regenerate

Neutrogena Boost Your Skins Vitals Team Regenerate

Approved
Approval ID

0acd9110-4ba5-227a-e063-6294a90ad942

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 1, 2025

Manufacturers
FDA

Kenvue Brands LLC

DUNS: 118772437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone, Homosalate, Octisalate, and Octocrylene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69968-0845
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Product Specifications
Effective DateJuly 1, 2025
FDA Product Classification

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/23/2023

PRINCIPAL DISPLAY PANEL - Kit Package

VALUE PACK

Neutrogena®

BOOST YOUR SKIN’S VITALS™

TEAM

REGENERATE

VISIBLY

SMOOTHS*

FINE LINES

IN 1 WEEK

+ PROTECTS

SKIN**

CONTENTS: 1 NEUTROGENA®

RAPID WRINKLE REPAIR® RETINOL

REGENERATING CREAM FRAGRANCE

FREE NET WT. 1.7 OZ. (48 g),

1 NEUTROGENA® HYDRO BOOST

HYALURONIC ACID MOISTURIZER WITH

SUNSCREEN SPF 50 FRAGRANCE FREE

1.7 FL. OZ. (50 mL)

*THE LOOK OF RAPID WRINKLE REPAIR®

REGENERATING CREAM

**HYDRO BOOST MOISTURIZER WITH SPF 50

PROVIDES BROAD SPECTRUM UVA/UVB

PROTECTION

Neutrogena_01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/23/2023

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 SECTION

LOINC: 34071-1Updated: 11/23/2023

Warnings

For external use only

Do not use on 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 11/23/2023

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/23/2023

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/23/2023

Purpose

Sunscreen

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/23/2023

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 11/23/2023

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/23/2023

Inactive ingredients

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Caprylic/Capric Triglyceride, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Styrene/Acrylates Copolymer, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Hydrolyzed Hyaluronic Acid, Hydroxymethoxyphenyl Decanone, Sodium Hydroxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/23/2023

Questions?

Call toll-free800-582-4048 or 215-273-8755 (collect) or visit www.neutrogena.com

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