Home NDC 68828-444 Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)
Product NDC 68828-444
11-digit product format 688280444
Labeler code 68828
Product ID 68828-444_2abe084b-74b1-e923-e063-6394a90ac941
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler Distribuidora Comercial Jafra, S.A. de C.V.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-10
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 68828-444 68828-444-02 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a poison Control Center right away
Additional Listing Data#
Finished product Yes
Brand name base Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 10 g/100mL
Harmonized Identifiers# Field, Values table Field Values Unii G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68828-444-01 Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) 50 mL in 1 BOTTLE CREAM 50 6 68828-444-02 Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) 7.5 mL in 1 TUBE CREAM 7.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68828-444 TENDER MOMENTS BABY SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (40 MINUTES) (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.] 6 Current NDC, Legacy NDC, 2 package rows 20250104_c3bacceb-63a8-098c-e053-2995a90acd64.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68828-444-01 68828044401 50 mL in 1 BOTTLE (68828-444-01) 50 ml 2021-06-10 0000-00-00 No No Current 68828-444-02 68828044402 7.5 mL in 1 TUBE (68828-444-02) 7.5 ml 2021-06-10 0000-00-00 No No Current