FDA.reportPublic FDA data

SPECIFIC BEAUTY DAILY HYDRATING LOTION SPF 30

Manufacturer
Somabella Laboratories, LLC
Effective date
2019-04-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:59:06

Label at a glance#

ProductSPECIFIC BEAUTY DAILY HYDRATING SPF 30
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTINOXATE, OXYBENZONE, OCTISALATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

AVOBENZONE - 3 percent

OCTOCRYLENE - 2.4 percent

OCTINOXATE - 5 percent

OXYBENZONE - 5 percent

OCTISALATE - 5 percent

WARNINGS SECTION

WARNINGS: FOR EXTERNAL USE ONLY

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 or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Children under 6 months ask a doctor.

After using Skin Brightening Serum, apply lotion to the entire face and neck.  For best results, continued use of the complete Specific Beauty regimen is recommended.

DESCRIPTION SECTION

Questions or for more information, please call: 877-358-1122

www.specificbeauty.com

Distributed by: Somabella Laboratories, LLC

247 SW ith St., #200, Miami FL 33130

Made in USA   #43703

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), CAPRYLYL METHICONE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, NIACINAMIDE, STEARETH-21, CETEARYL ALCOHOL, GLYCERIN, ETHYLHEXYL METHOXYCRYLENE, ALUMINUM STARCH OCTENYL SUCCINATE, BORON NITRIDE, PHENOXYETHANOL, PHYLLANTHUS EMBLICA FRUIT EXTRACT BEHENYL ALCOHOL, POLYACRYLATE-13, POLYISOBUTENE, CETEARYL GLUCOSIDE, ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE, XANTHAN GUM, POLYSORBATE 20,

CHLORPHENESIN, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, PHOSPHOLIPIDS, LINOLEIC ACID PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPECIFIC beauty For multi-hued skin tones

Daily Hydrating Lotion; SPF 30

STEP 3 BRIGHTENS SKIN

UVA/UVB Protection

DERMATOLOGIST DESIGNED REGIMEN

2 FL OZ (60 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Specific BeautySpecific Beauty

IngredientsIngredients

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52295-200-602021-01-29C16284748780-1ba0f9c33-2f8b-a910-e053-dadaa90a0b85SPECIFIC BEAUTY DAILY HYDRATING LOTION SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52295-200-60SPECIFIC BEAUTY DAILY HYDRATING SPF 3060 mL in 1 PACKAGELOTION605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52295-200SPECIFIC BEAUTY DAILY HYDRATING SPF 30 (AVOBENZONE,OCTOCRYLENE,OCTINOXATE,OXYBENZONE,OCTISALATE) LOTION [SOMABELLA LABORATORIES, LLC]5Legacy NDC, 1 package rows20190405_fcc71c0f-a769-4675-978c-63fe3f7d93d3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX3
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
OCTISALATEACTIVE INGREDIENT4X49Y0596W3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y3
AVOBENZONEACTIVE MOIETYG63QQF2NOX3
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
OCTISALATEACTIVE MOIETY4X49Y0596W3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM3
OXYBENZONEACTIVE MOIETY95OOS7VE0Y3
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O62943
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BU3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CAPRYL METHICONEINACTIVE INGREDIENTJ7960S4R1T3
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNA3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XY3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H3
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ3
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD43
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3
STEARETH-21INACTIVE INGREDIENT53J3F32P583
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

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
52295-20052295-200-60

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
MYRISTYL TRISILOXANEJ7960S4R1TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NIACINAMIDE25X51I8RD4IACT
STEARETH-2153J3F32P58IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DOCOSANOL9G1OE216XYIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 207T1F30V5YHIACT
CHLORPHENESINI670DAL4SZIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
LINOLEIC ACID9KJL21T0QJIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB

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 4 · 238 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / TOPICAL3.7 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
DOCOSANOLDOCOSANOL9G1OE216XYAEROSOL, FOAM / TOPICAL1.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 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
85b66774-93c8-d76c-e053-2a91aa0a99d3fcc71c0f-a769-4675-978c-63fe3f7d93d32019-04-04WarningsExact identifier
spl id: 85b66774-93c8-d76c-e053-2a91aa0a99d3
spl set id: fcc71c0f-a769-4675-978c-63fe3f7d93d3

Reported adverse events (FAERS/openFDA)#

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