FDA.reportPublic FDA data

Avobenzone, Octinoxate, Octisalate and Oxybenzone

Manufacturer
Meaningful Beauty, LLC
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:02

Label at a glance#

ProductMeaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15
Active ingredientAvobenzone, Octinoxate, Octisalate, Oxybenzone
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

apply generously 15 minutes before sun exposure reapply at least every 2 hours 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....

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • 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-sleeve shirts, pants, hats, and sunglasses
    • use a water resistant sunscreen if swimming or sweating

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Neopentyl Glycol Diheptanoate, Dicaprylyl Carbonate, Cetearyl Alcohol, Butylene Glycol, Glycerin, PEG-40 Stearate, PEG-100 Stearate, Glyceryl Stearate, Dimethicone, Cucumis Melo (Melon) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, Ascorbyl Methylsilanol Pectinate, Magnesium Ascorbyl Phosphate, Tetrapeptide-21, Biosaccharide Gum-1, Dipotassium Glycyrrhizate, Caprylyl Glycol, Hydrogenated Vegetable Oil, Alcohol, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Cholesterol, Ethylhexylglycerin, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Steareth-20, Disodium EDTA, Potassium Sorbate, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol, Fragrance

Questions or Comments?

OTC - QUESTIONS SECTION

Within US 1-800-927-0047

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEANINGFUL
BEAUTY
CINDY CRAWFORD

SKIN BRIGHTENING
DÉCOLLETÉ AND
NECK TREATMENT

Broad Spectrum
SPF 15 Sunscreen

50 mL / 1.7 FL OZ

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
PRINCIPAL DISPLAY PANEL - 50 mL Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84068-002-01Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 1520 mL in 1 TUBECREAM201
84068-002-02Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 1550 mL in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84068-002MEANINGFUL BEAUTY CINDY CRAWFORD SKIN BRIGHTENING DECOLLETE AND NECK TREATMENT BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE) CREAM [MEANINGFUL BEAUTY, LLC]1Current NDC, 2 package rows20250515_f59fe019-569b-49ba-accf-fa4d356ce96b.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84068-00284068-002-01, 84068-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Oxybenzone95OOS7VE0YACTIB
water059QF0KO0RIACT
Neopentyl Glycol Diheptanoate5LKW3C543XIACT
Dicaprylyl Carbonate609A3V1SUAIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Butylene Glycol3XUS85K0RAIACT
GlycerinPDC6A3C0OXIACT
PEG-40 MONOSTEARATEECU18C66Q7IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
Dimethicone92RU3N3Y1OIACT
MUSKMELONZV095H5633IACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
Ascorbyl Methylsilanol PectinateM3PF9237YCIACT
Magnesium Ascorbyl Phosphate0R822556M5IACT
Tetrapeptide-21179JUC43HUIACT
Biosaccharide Gum-1BB4PU4V09HIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
Caprylyl Glycol00YIU5438UIACT
HYDROGENATED PALM OIL257THB963HIACT
Alcohol3K9958V90MIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
SOYBEAN PHOSPHATIDYLCHOLINE1T6N4D9YV6IACT
Cholesterol97C5T2UQ7JIACT
Ethylhexylglycerin147D247K3PIACT
Polysorbate 60CAL22UVI4MIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
Steareth-20L0Q8IK9E08IACT
EDETATE DISODIUM7FLD91C86KIACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium Hydroxide55X04QC32IIACT
ChlorphenesinI670DAL4SZIACT
PhenoxyethanolHIE492ZZ3TIACT

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
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONEMeaningful Beauty, LLCf59fe019-569b-49ba-accf-fa4d356ce96b2025-05-12WarningsExact identifier
ndc (package): 84068-002-01
ndc (package): 84068-002-02
ndc (product): 84068-002
ndc11 (package): 84068000201
ndc11 (package): 84068000202
spl id: 715edfd0-0e0a-44e5-9cdf-ece473cfc5cc
spl set id: f59fe019-569b-49ba-accf-fa4d356ce96b

Reported adverse events (FAERS/openFDA)#

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