FDA.reportPublic FDA data

21st Century Formulations - Skin MD Natural TM Shielding Lotion (44099-001)

Manufacturer
21st Century Formulations
Effective date
2022-01-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:16:22

Label at a glance#

Productskin MD Natural
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

SkinMD_LabelSkinMD_Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G1
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ1
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST)INACTIVE INGREDIENT7K226YI89Y1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1X1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C51
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11P1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD561

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
44099-00144099-001-01, 44099-001-02, 44099-001-03, 44099-001-04, 44099-001-05

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
ALOE VERA LEAFZY81Z83H0XIACT
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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET / ORAL19 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CAPSULE / ORAL288 mgExact identifier — unii candidate
16 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SOLUTION / ORAL1080 mgExact identifier — unii candidate
16 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CREAM / TOPICAL11000 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, COATED / ORAL0.13 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56EMULSION / TOPICAL34050 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SYSTEM / TRANSDERMAL2.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
16 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LEMULSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56LOTION / TOPICAL7 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii candidate
16 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii candidate
2 equally ranked IID candidates
METHYL GLUCETH-20METHYL GLUCETH-20J3QD0LD11PCREAM / TOPICAL5 %w/wExact identifier — unii candidate
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SPRAY / TOPICAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
CHONDRUS CRISPUSCHONDRUS CRISPUSOQS23HUA1XLOTION / TOPICALNAExact identifier — unii candidate
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, FILM COATED / ORAL12 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SUPPOSITORY / RECTAL390 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56GEL / TOPICAL20 mgExact identifier — unii candidate
16 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
2f2ce95c-d331-9e71-e063-6294a90a32785697b8cf-7d03-4f97-b7f6-b3bd926f20f92025-02-27WarningsExact identifier
spl set id: 5697b8cf-7d03-4f97-b7f6-b3bd926f20f9

Reported adverse events (FAERS/openFDA)#

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