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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact 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