FDA.reportPublic FDA data

SPF 30 Moisturizer with Aloe Vera

Manufacturer
Audrey Morris Cosmetics International, LLC
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:58

Label at a glance#

ProductSPF 30 Moisturizer with Aloe Vera
Active ingredientHOMOSALATE, OCTOCRYLENE, 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 aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure 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 early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, ...

Label contents#

Full prescribing information#

Active Ingredients                          Purpose

OTC - ACTIVE INGREDIENT SECTION

Homosalate 7.0%                          Sunscreen
Octocrylene 5.0%                          Sunscreen
Avobenzone 2.0%                          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 aging caused by the sun.

Warnings

WARNINGS SECTION

For Extranal use only
Do not use ondamaged or broken skin.
When using this product

  • Keep out of eyes. Rinse with water to remove

Stop use and ask doctor

  • Rash or irritation develops and lasts

Keep out of reach if children

  • If product gets swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • 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 early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10:00a.m – 2:00p.m
  • Wear long sleave shirts, pants, hats, and sunglasses.
  • Children under 6 Months: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direact sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Adipic Acid, Adipic Acid/Diglycol Crosspolymer, Isopropyl Myristate, Polyester-8, Propylene Glycol, Hydrogenated Polyisobutene, Cetyl alcohol, Sorbitan Stearate, Fragrance, Aloe Barbadensis Leaf Extract, Allantoin, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Phenoxyethanol, Disodium EDTA, Caprylyl Glycol.

Questions or Comments?

SPL UNCLASSIFIED SECTION

1-800-826-8287

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83695-001-012025-07-31C16284748780-12cef2736-b18f-d83d-e063-dadaa90ab31f0828593a-fa3e-42ae-8f9f-59787843bf39
83695-001-012025-01-30C16284748780-12cef2736-b18f-d83d-e063-dadaa90ab31f0828593a-fa3e-42ae-8f9f-59787843bf39

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83695-001-01SPF 30 Moisturizer with Aloe Vera170 mL in 1 BOTTLECREAM1702

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83695-00183695-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ADIPIC ACID76A0JE0FKJIACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
CETYL ALCOHOL936JST6JCNIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
TROLAMINE9O3K93S3TKIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
POLYSORBATE 207T1F30V5YHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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
3b3e0d0b-d390-c401-e063-6394a90a16d20828593a-fa3e-42ae-8f9f-59787843bf392025-07-31WarningsExact identifier
spl id: 3b3e0d0b-d390-c401-e063-6394a90a16d2
spl set id: 0828593a-fa3e-42ae-8f9f-59787843bf39

Reported adverse events (FAERS/openFDA)#

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