FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85374-203
11-digit product format
853740203
Labeler code
85374
Product ID
85374-203_46166f9a-eb13-f756-e063-6294a90aa42d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
BABYFACE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-08
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 mg/g; mg/g
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
Tinted Mineral Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE38 mg/g
TITANIUM DIOXIDE80 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36d69eb5-59b4-14a0-e063-6394a90a0a49Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85374-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

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 288 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a6296612-184c-6b3c-e053-2a95a90a34b92024-10-14WarningsExact identifier
application number: M020
OPEN NATURE SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6020d2f-55c4-adfc-e053-2a95a90ad2382024-10-14WarningsExact identifier
application number: M020
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6044f0f-eb86-684d-e053-2995a90a09212024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a62848fb-7016-3457-e053-2a95a90aa0f12024-10-14WarningsExact identifier
application number: M020
Safeway Signature Care Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENESafeway, Inc.c6a0ae3e-d68a-b838-e053-2a95a90a77f72024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a628ff71-463d-4d39-e053-2995a90a7a422024-10-14WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONESafeway, Inc.c5106c63-af51-c169-e053-2a95a90afef22024-10-14WarningsExact identifier
application number: M020
Safeway Signature Care Dry Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESafeway, Inc.c6267a29-46a5-5f38-e053-2a95a90a01172024-10-14WarningsExact identifier
application number: M020
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30ZINC OXIDESafeway, Inc.dbeff8e8-250d-8274-e053-2995a90a984e2024-10-14WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, ZINC OXIDERare Beauty, LLC2460281d-d433-0216-e063-6394a90a9d482024-10-13WarningsExact identifier
application number: M020
Walgreens 50 Coconut Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436987c-2afe-06b5-e063-6394a90aceba2024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Banana Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436bd19-2299-6e89-e063-6394a90acd992024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf07238df-4970-7759-e053-2a95a90a39f92024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 70 Sport ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWALGREEN COMPANYe7165b39-54f9-4af6-e053-2a95a90af6642024-10-11WarningsExact identifier
application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf14bb3b4-1dce-06b9-e053-2995a90a8bc82024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf12c9767-7cb7-12c8-e053-2995a90a17be2024-10-11WarningsExact identifier
application number: M020
Sulwhasoo UV Daily CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAMAmorepacific Corporatione00451d5-8433-c4e8-e053-2a95a90a62442024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Sport Continuous SunscreenAVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf13ec3da-2dc2-04f7-e053-2995a90a198d2024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf4155692-16a7-11e8-e053-2995a90abd342024-10-11WarningsExact identifier
application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf906792b-083e-13e2-e053-6294a90ab4cf2024-10-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85374-203-508537402035053 g in 1 BOTTLE, PUMP (85374-203-50) 53 g2019-07-08NoNoCurrent