FDA.reportPublic FDA data

restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex

Product NDC
57670-000
11-digit product format
576700000
Labeler code
57670
Product ID
57670-000_0c5b67fe-115a-254e-e063-6394a90a07ce
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
RESTORSEA INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-24
Substance
ZINC OXIDE
Active strength
20 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244637Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57670-000-00restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex50 g in 1 TUBELOTION507
57670-000-00restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex1 in 1 CARTONLOTION17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
ALARIA ESCULENTAINACTIVE INGREDIENTEJ9JK8J58DRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
ASCORBYL GLUCOSIDEINACTIVE INGREDIENT2V52R0NHXWRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JORESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
DICAPRYLYL ETHERINACTIVE INGREDIENT77JZM5516ZRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
GLYCERYL CAPRYLATEINACTIVE INGREDIENTTM2TZD4G4ARESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784URESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7URESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ERESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
WATERINACTIVE INGREDIENT059QF0KO0RRESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEERESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57670-000RESTORSEA REJUVENATING DAY SPF 30 BROAD SPECTRUM UVA UVB WITH VIBRANSEA COMPLEX (ZINC OXIDE) LOTION [RESTORSEA INC]7Current NDC, Legacy NDC, 2 package rows20231213_80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a.zip

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 18 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC235a9430-b445-8d5c-e063-6394a90a93542026-06-24WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244637zinc oxide 20 % Topical LotionPSN80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a7
244637zinc oxide 200 MG/ML Topical LotionSCD80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a7
244637ZnO 20 % Topical LotionSY80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a7
244637ZNO 200 MG/ML Topical LotionSY80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57670-000-00576700000001 TUBE in 1 CARTON (57670-000-00) / 50 g in 1 TUBE1 tube2017-12-190000-00-00NoNoCurrent