Home NDC 71070-768 JACKET SPF 50
Product NDC 71070-768
11-digit product format 710700768
Labeler code 71070
Product ID 71070-768_0974579b-6f81-6b47-e063-6294a90a0217
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE
Dosage form CREAM
Route TOPICAL
Labeler Balshi MD Dermaceuticals
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-18
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 75; 75; 50; 50 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 JACKET SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 75 mg/g OCTINOXATE 75 mg/g OCTISALATE 50 mg/g OXYBENZONE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71070-768-04 JACKET SPF 50 1 in 1 CARTON CREAM 1 3 71070-768-04 JACKET SPF 50 113 g in 1 BOTTLE CREAM 113 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71070-768 JACKET SPF 50 (ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE) CREAM [BALSHI MD DERMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20231106_b82b8a46-8009-416e-8718-296a23106914.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 163 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunsolve MD Firm and Replenish ZINC OXIDE Sunsolve MD Inc 26f3417b-9ea4-e577-e063-6294a90ae53c 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Correct and Fade ZINC OXIDE Sunsolve MD Inc 26f3ad9f-f8ca-05d4-e063-6394a90ad5c4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Volumize and Condition Lip ZINC OXIDE Sunsolve MD 396b7462-d597-4bf7-e063-6394a90ab58d 2025-11-14 Warnings Exact identifier application number: M020 Sunsovle MD Volumize and Restore ZINC OXIDE Sunsolve MD Inc 26f3cdda-b990-15cb-e063-6394a90ade29 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew-Glow Moisturizer SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc 0a5b80fb-caeb-eb56-e063-6294a90a238b 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d82f310-f87a-f76d-e063-6294a90af251 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50-deep HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d865e74-1baf-6a44-e063-6394a90a37ac 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50-medium HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d8616a8-2eab-c85c-e063-6294a90a3984 2025-11-14 Warnings Exact identifier application number: M020 Naturium UV Reflect Antioxidant SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc 0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c 2025-11-14 Warnings Exact identifier application number: M020 CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc 372894af-bed7-474f-95d4-69a8c3f215ef 2025-11-14 Warnings Exact identifier application number: M020 HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ONEAND CO., LTD. 2dc41560-f4a7-5f0b-e063-6294a90a0630 2025-11-13 Warnings Exact identifier application number: M020 Covey Sun and Done Daily Moisturizing ZINC OXIDE Covey Skin fbcf8204-0673-99aa-e053-6294a90ac26e 2025-11-13 Warnings Exact identifier application number: M020 SOL Science The Fifty ZINC OXIDE Beauty Pie 01548858-8b0e-494a-e063-6294a90a8e99 2025-11-13 Warnings Exact identifier application number: M020 Balmere Mineral Sunscreen Moisturizer Primer ZINC OXIDE Balmere 00d813e0-eb97-a6ba-e063-6394a90aa525 2025-11-13 Warnings Exact identifier application number: M020 Dove Clinical Care 96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANT Conopco d/b/a Unilever 437eb2a8-428c-8339-e063-6394a90a74b2 2025-11-13 Warnings Exact identifier application number: M020 Dove Clinical Care 96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANT Conopco d/b/a Unilever 437f4db5-552f-1550-e063-6394a90aaedb 2025-11-13 Warnings Exact identifier application number: M020 Depology Essential Mineral UV Care ZINC OXIDE Depology Holdings LLC 1d48cdee-be67-14c0-e063-6294a90a7422 2025-11-13 Warnings Exact identifier application number: M020 Hanalei Face Moisturizing ZINC OXIDE Hanalei Beauty Company LLC 1f7c1a68-5aea-0deb-e063-6394a90a3a43 2025-11-13 Warnings Exact identifier application number: M020 Glo Skin TITANIUM DIOXIDE, ZINC OXIDE Glo Skin Beauty f4bed574-68c1-0d2c-e053-2a95a90a15ff 2025-11-13 Warnings Exact identifier application number: M020 Dove Clinical Care 96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANT Conopco d/b/a Unilever 4380036a-7698-03e7-e063-6294a90a7301 2025-11-13 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71070-768-04 71070076804 1 BOTTLE in 1 CARTON (71070-768-04) / 113 g in 1 BOTTLE 1 bottle 2016-11-18 0000-00-00 No No Current