Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick

Product NDC
53675-203
11-digit product format
536750203
Labeler code
53675
Product ID
53675-203_098688fd-eb12-29d6-e063-6294a90ade41
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-08
Substance
ZINC OXIDE
Active strength
200 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 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
3201cc8b-5fee-4f3b-a826-e349786d1b32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-203-00Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick30 mL in 1 CONTAINERSTICK302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-203SPORT BROAD SPECTRUM SPF50 WATER RESISTANT 80 MINUTES MINERAL SUNSCREEN UVA UVB PROTECTION STICK (ZINC OXIDE) STICK [ARUBA ALOE BALM NV]2Current NDC, Legacy NDC, 1 package rows20231108_3201cc8b-5fee-4f3b-a826-e349786d1b32.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 339 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.5720bd35-de4a-4db4-a4df-0fbc59719bfd2023-10-25WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated SPF 15OCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.ca20b2dc-97e5-461a-94c8-5c109cd152852023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.aeea02a0-233e-43b6-b1b8-95ae64b7fa002023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.41e4fca8-22c0-4a8a-95d3-e4aad559548a2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Honey Dew Melon SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2f721ae7-1922-4463-bb5f-64699907a6692023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.6ef888a3-77c0-498f-92c4-d482cf96ef462023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.4e868b1a-7c47-45de-83cd-0bd5fbb05a272023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.a298815d-9f1f-419d-9dad-6bbfcddc7a482023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb6086c1-f775-70ed-e053-2995a90a531e2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Sweets SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb62d499-1d78-1324-e053-2a95a90abe3c2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.f3eb98dc-9ab3-4123-9490-a1bbf9b3259a2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb132025-658f-d6f8-e053-2995a90a089b2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2caa7b23-2adb-4953-b044-1b1ad9a5798b2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bae876db-e410-64f6-e053-2995a90a9ebe2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb029c71-4f07-2754-e053-2995a90a7c782023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb28c2e7-4189-fc11-e053-2995a90a92ad2023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Favorites SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb611c57-a8ac-0c23-e053-2995a90a5b402023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bbf118c0-7cd5-5a82-e053-2a95a90ac8c82023-10-25WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.088b81e4-76c7-6680-e063-6294a90acb732023-10-25WarningsExact identifier
application number: M020
Cetaphil Hydrating Face Sunscreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.e924bfd5-d64d-4918-b57b-7d4da28bd0132023-10-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-203-005367502030030 mL in 1 CONTAINER (53675-203-00) 30 ml2022-03-080000-00-00NoNoCurrent