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 295 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 Sunscreen AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 01c9c677-9da1-47d9-8b7e-b21f8450c5c3 2024-06-26 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 Sunscreen AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 5ab9c228-28e2-43fc-8e0b-7f8e118cb388 2024-06-26 Warnings Exact identifier application number: M020 SEAWEED BATH CO SPF 40 SPORT AVOBENZONE, OCTISALATE, OCTOCRYLENE The Seaweed Bath Co. d64d4a52-0bea-4bbc-8d34-e16c1b4efe8c 2024-06-26 Warnings Exact identifier application number: M020 SEAWEED BATH CO Everyday Mineral SPF 40 ZINC OXIDE The Seaweed Bath Co. 8380bb3f-47d0-4675-b326-620ffb74dbdf 2024-06-26 Warnings Exact identifier application number: M020 Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc be2a83fb-e4f8-4313-b5bd-150f351fb345 2024-06-26 Warnings Exact identifier application number: M020 Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 Sunscreen AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 60689efb-2dd4-4322-a621-54eb2c3c3dc2 2024-06-26 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 Sunscreen AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE d8449209-65d0-43c6-8750-0f460a950157 2024-06-26 Warnings Exact identifier application number: M020 Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE SICOS ET CIE 066a0951-2e7e-40c0-8035-4d708a32f16c 2024-06-26 Warnings Exact identifier application number: M020 GUIDANCE TO GLOW TRU SPF 35 ZINC OXIDE GUIDANCE TO GLOW SKIN CARE 21b4747b-b173-43c9-b0d4-1dbba5775ff8 2024-06-25 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide ZINC OXIDE Fallien Cosmeceuticals, Ltd 1bbd14ec-4240-f0c2-e063-6394a90a2c07 2024-06-25 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 0200a00f-2b57-454d-933d-a7d48644be6e 2024-06-25 Warnings Exact identifier application number: M020 Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen ENSULIZOLE L'Oreal USA Products Inc 8e48e675-0b4f-4b91-85de-c4e29be65147 2024-06-25 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 427a21cc-a668-4af8-94cb-b981d5c1919f 2024-06-25 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 451e50a2-2dd7-4c90-88c9-b9f9056d7ee3 2024-06-25 Warnings Exact identifier application number: M020 Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen ENSULIZOLE SICOS ET CIE 979db22b-97eb-4818-aa01-1288b56e38b5 2024-06-25 Warnings Exact identifier application number: M020 Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant ZINC OXIDE SQWEEN LLC b5bf1c4c-7c48-423c-b4fc-52ae57f339fd 2024-06-24 Warnings Exact identifier application number: M020 BANANA BOAT ZINC OXIDE Edgewell Personal Care Brands LLC 1ba50f16-4b76-825f-e063-6294a90a2a4d 2024-06-24 Warnings Exact identifier application number: M020 BANANA BOAT ZINC OXIDE Edgewell Personal Care Brands LLC 1ba57692-c36d-ef4a-e063-6394a90a1236 2024-06-24 Warnings Exact identifier application number: M020 Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation OCTINOXATE AND TITANIUM DIOXIDE SICOS ET CIE 66a91768-6012-485a-b569-a293ea6d4880 2024-06-24 Warnings Exact identifier application number: M020 Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc 43539766-2e70-4b42-b64b-1d30367b2eb9 2024-06-24 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