FDA.reportPublic FDA data

Sun Guard

Product NDC
70983-024
11-digit product format
709830024
Labeler code
70983
Product ID
70983-024_4851c3b3-b351-8628-e063-6294a90ad4ba
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Saje Natural Business Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-09
Substance
ZINC OXIDE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Sun Guard
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87ee593d-668c-f592-e053-2a95a90a17b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-024-01Sun Guard100 mL in 1 TUBELOTION1005
70983-024-02Sun Guard180 mL in 1 TUBELOTION1805
70983-024-03Sun Guard50 mL in 1 TUBELOTION505
70983-024-03Sun Guard1 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-024SUN GUARD (ZINC OXIDE) LOTION [SAJE NATURAL BUSINESS INC]4Current NDC, Legacy NDC, 4 package rows20231006_87ee593d-668c-f592-e053-2a95a90a17b1.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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
application number: M020
Aruba Sun SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd96b4233-6d52-7621-e053-2a95a90a1b602023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltddee4bdb8-5c6f-42f6-b15c-d109cd2d31402023-11-08WarningsExact identifier
application number: M020
Mineral Radiance Energizing Day BS SPF 15AVOBENZONE, HOMOSALATE, AND OCTISALATEAHAVA Dead Sea Laboratories Ltd4cb8b21c-7727-441a-9d61-c90d79ac45dc2023-11-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Passion FruitAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLCf34beb68-e5dc-45c4-a6d1-e9a0310162282023-11-08WarningsExact identifier
application number: M020
Private Label SPF45 Water Resistant Paraben Free SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCf997f4fc-7da5-433c-9a53-2030b489b4f62023-11-07WarningsExact identifier
application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43SUNSCREENSwiss-American CDMO, LLC003e4221-f9d9-47c4-b10b-9876046b931a2023-11-07WarningsExact identifier
application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltd5a9ec221-a9ec-4473-8fb0-83f10ae775e22023-11-07WarningsExact identifier
application number: M020
Private Label Super Light Oil-Free SPF452.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC6a08448a-46bc-4330-ae2d-f716bb4edfa72023-11-07WarningsExact identifier
application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30OCTINOXATE, OCTISALATE, ZINC OXIDETT Fitness, Inc617ef3af-4203-4664-b714-1b5fab2e0ee62023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30ZINC OXIDEThe Seaweed Bath Co.c241261c-d887-4ac2-89ce-93dcc0fce2672023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC88628c11-dbc7-4404-9701-7944a685a13d2023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50ZINC OXIDEThe Seaweed Bath Co.fdcfc7eb-da33-4461-a4f9-fe97ea6b873f2023-11-06WarningsExact identifier
application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INC183e523a-93ee-47ec-8bd4-5557af449ea52023-11-06WarningsExact identifier
application number: M020
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC4e05e9d6-5127-44ca-a331-3004b2ddb5342023-11-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-024-0170983002401100 mL in 1 TUBE (70983-024-01) 100 ml2019-05-090000-00-00NoNoCurrent
70983-024-0270983002402180 mL in 1 TUBE (70983-024-02) 180 ml2019-05-090000-00-00NoNoCurrent
70983-024-03709830024031 TUBE in 1 BOX (70983-024-03) / 50 mL in 1 TUBE1 tube2019-06-250000-00-00NoNoCurrent