FDA.reportPublic FDA data

SPF 50 Mineral Sunscreen Face and Body

Product NDC
85865-002
11-digit product format
858650002
Labeler code
85865
Product ID
85865-002_52cc5adc-9233-e0ff-e063-6394a90a227e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Toddle Born Wild, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-10
Substance
ZINC OXIDE
Active strength
20 g/100mL
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
SPF 50 Mineral Sunscreen Face and Body
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

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
e97d82fe-cd45-43a5-9c1f-3900025240a1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85865-002-01SPF 50 Mineral Sunscreen Face and Body50 mL in 1 TUBELOTION503
85865-002-02SPF 50 Mineral Sunscreen Face and Body100 mL in 1 TUBELOTION1003
85865-002-03SPF 50 Mineral Sunscreen Face and Body177 mL in 1 PACKAGELOTION1773

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 182 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
application number: M020
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
application number: M020
Summer Face Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCfe256ff4-cb92-4262-8ab9-7cc912e0af222025-10-06WarningsExact identifier
application number: M020
Sun Veil Broad Spectrum SPF50ZINC OXIDEMONAT GLOBAL CORP3ba28de7-74a2-5cde-e063-6394a90add262025-10-06WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
application number: M020
Apple Lip Balm with Aloe VeraBROAD SPECTRUM SPF 15 SUNSCREEN LIP BALMDurvet, Inc.6dcbb2cd-e690-4970-8cf1-08ca539d36022025-10-06WarningsExact identifier
application number: M020
PURE SOL SPF 50 Daily MoisturizerZINC OXIDEBrand 2022b LLC4051506c-fc13-cd22-e063-6394a90a977e2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer)ZINC OXIDEBrand 2022b LLC4051ced5-85cf-6211-e063-6394a90a09fc2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 30 Mineral Whipped SunscreenZINC OXIDEBrand 2022b LLC4051d241-6890-2b06-e063-6294a90aa09d2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 - Vanilla OrchidAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7a9722-d211-e861-e063-6294a90a6cdc2025-10-02WarningsExact identifier
application number: M020
Kids Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
application number: M020
HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVBSUNSCREEN SPF 50IHerb, LLC3cab1598-5ef3-df73-e063-6394a90ab1e22025-10-01WarningsExact identifier
application number: M020
Moisturizing Rich Sunscreen SPF 30ZINC OXIDEGood Molecules, LLC36c3ba26-ca25-7498-e063-6294a90a47fc2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30 Shade 1ZINC OXIDEDime Beauty Co, LLC07104cbf-0446-a053-e063-6394a90ab41f2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3ZINC OXIDEDime Beauty Co, LLC07503a1f-d530-e3bb-e063-6294a90a8ae32025-10-01WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEDime Beauty Co, LLCe38deed3-e1e2-0b1d-e053-2a95a90a547f2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Tinted Broad Spectrum SPF 30ZINC OXIDEDime Beauty Co, LLCf2a59fa4-f19c-a15f-e053-2a95a90a6ace2025-10-01WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414b88ca-a3df-5e42-e063-6294a90a69ba2025-10-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85865-002-018586500020150 mL in 1 TUBE (85865-002-01) 50 ml2025-12-10NoNoCurrent
85865-002-0285865000202100 mL in 1 TUBE (85865-002-02) 100 ml2026-02-10NoNoCurrent
85865-002-0385865000203177 mL in 1 PACKAGE (85865-002-03) 177 ml2025-12-10NoNoCurrent