FDA.reportPublic FDA data

AGELESS SOLAR DEFENSE (SPF 30)

Manufacturer
Divine 369 LLC
Effective date
2023-01-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:39

Label at a glance#

ProductAGELESS SOLAR DEFENSE (SPF 30)
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure8 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

Apply liberally to face and body at least 15 minutes before sun exposure or two minutes before applying makeup. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying. At least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher a...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 4.0%
Avobenzone 3.0%

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.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

Stop use and contact your doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help, or contact a poison control center right away.

  • Do not apply too closely to the eye area. Rinse with water to remove.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to face and body at least 15 minutes before sun exposure or two minutes before applying makeup.
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying.
  • At least every 2 hours.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and 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 specially, 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

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Palmitate, Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Ethylhexyl Methoxycrylene, Silica, Cetyl Dimethicone, Hydroxyethylacrylate/sodium acryloyldimethyl taurate copolymer, Dimethicone, Polyglyceryl-3 Diisostearate, Cetearyl Alcohol, Polysorbate 60, Isohexadecane, Hydroxyethylcellulose, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Butylene Glycol, Punica Granatum (Pomegranate) Extarct, Camellia Oleifera Leaf Extract

Questions or Comments?

OTC - QUESTIONS SECTION

Contact us at: contact@audiaskincare.com

Monday - Friday (9am - 5pm PST)

Dist-by Divine 369 LLC. San Francisco CA, 94124

www.audiaskincare.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82084-0011-02025-01-30C16284748780-1f386c64a-323c-0266-e053-dadaa90a7c1aAGELESS SOLAR DEFENSE (SPF 30)
82084-0011-02023-01-31C16284748780-1f386c64a-323c-0266-e053-dadaa90a7c1aAGELESS SOLAR DEFENSE (SPF 30)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82084-0011-0AGELESS SOLAR DEFENSE (SPF 30)50 mL in 1 BOTTLE, PUMPCREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82084-0011AGELESS SOLAR DEFENSE (SPF 30) (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [DIVINE 369 LLC]3Legacy NDC, 1 package rows20230202_56619591-07f2-4ad9-9d06-2930491b191b.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82084-001182084-0011-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ISOEICOSANEAR294KAG3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
ISOHEXADECANE918X1OUF1EIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POMEGRANATE56687D1Z4DIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB

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
f399685c-ad12-2344-e053-2995a90afe0256619591-07f2-4ad9-9d06-2930491b191b2023-01-31WarningsExact identifier
spl id: f399685c-ad12-2344-e053-2995a90afe02
spl set id: 56619591-07f2-4ad9-9d06-2930491b191b

Reported adverse events (FAERS/openFDA)#

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