Home NDC 76138-222 5283 Sunscreen
Product NDC 76138-222
11-digit product format 761380222
Labeler code 76138
Product ID 76138-222_1cee8d76-1faa-14b4-e063-6294a90afc0e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octocrylene, Octisalate
Dosage form LOTION
Route TOPICAL
Labeler Innovation Specialties
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-31
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 3; 10; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL
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 5283 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL OCTOCRYLENE 10 g/100mL OCTISALATE 5 g/100mL
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76138-222-01 5283 Sunscreen 30 mL in 1 BOTTLE, PLASTIC LOTION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76138-222 5283 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES] 2 Current NDC, 1 package rows 20240712_3a06bb05-5965-4d7d-a299-3d48b163c604.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 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 SOME BY MI V10 HYAL AIR FIT SUNSCREEN SUNSCREENT PERENNEBELL fe2148db-9020-9343-e053-6294a90adf70 2025-11-13 Warnings Exact identifier application number: M020 skin MD OCTINOXATE, OCTISALATE, HOMOSALATE 21st Century Formulations e809e1d3-0a6d-730d-e053-2a95a90aedb9 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 Sample Exclude flag Status 76138-222-01 76138022201 30 mL in 1 BOTTLE, PLASTIC (76138-222-01) 30 ml 2023-10-31 No No Current