FDA.reportPublic FDA data

skin MD

Manufacturer
21st Century Formulations
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:16:16

Label at a glance#

Productskin MD
Active ingredientOCTINOXATE, OCTISALATE, HOMOSALATE
Label structure13 sections

Indications and uses

Helps prevent sunburn. Decreases the risk of skin cancer and early aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Spending time in the sun increases your risk of skin cancer and early skin aging.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7%

Octisalate 5%

Homosalate 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Decreases the risk of skin cancer and early 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 ask a Doctor

OTC - STOP USE SECTION

if rash occurs.

When using this product

SPL UNCLASSIFIED SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.

    Spending time in the sun increases your risk of skin cancer and early skin aging.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Extracts of Arnica Montana Flower (Arnica), Symphytum Officinale Leaf (Camfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Oleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-540-4790

®2013 Made in USA

21st Century Formulations

Beverly Hills, CA 90210

www.skinmdnatural.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Skin MD_Shielding Lotion_SPF15_4oz01b LBL_Skin MD_Shielding Lotion_SPF15_4oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44099-011-01skin MD117 mL in 1 BOTTLELOTION1177
44099-011-02skin MD236 mL in 1 BOTTLELOTION2367
44099-011-03skin MD3785 mL in 1 BOTTLELOTION37857
44099-011-04skin MD100 mL in 1 TUBELOTION1007
44099-011-05skin MD200 mL in 1 TUBELOTION2007

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44099-01144099-011-01, 44099-011-02, 44099-011-03, 44099-011-04, 44099-011-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
METHYL GLUCETH-20J3QD0LD11PIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
COMFREY LEAFDG4F8T839XIACT
CHAMOMILEFGL3685T2XIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
CHONDRUS CRISPUSOQS23HUA1XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST)7K226YI89YIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
ndc (package): 44099-011-01
ndc (package): 44099-011-05
ndc (package): 44099-011-04
ndc (package): 44099-011-03
ndc (package): 44099-011-02
ndc (product): 44099-011
ndc11 (package): 44099001101
ndc11 (package): 44099001102
ndc11 (package): 44099001103
ndc11 (package): 44099001105
ndc11 (package): 44099001104
spl id: 4384c3d1-e160-67fa-e063-6394a90a0a42
spl set id: e809e1d3-0a6d-730d-e053-2a95a90aedb9

Reported adverse events (FAERS/openFDA)#

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