Home NDC 69219-103 EXTREME PROTECT SPF 30
Product NDC 69219-103
11-digit product format 692190103
Labeler code 69219
Product ID 69219-103_50c44fa3-d2c0-2939-e063-6394a90af3b5
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler SCIENCE OF SKINCARE LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-01
Substance OCTINOXATE; ZINC OXIDE
Active strength 5.5; 4.12 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 EXTREME PROTECT SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 5.5 g/100g ZINC OXIDE 4.12 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
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 69219-103-01 EXTREME PROTECT SPF 30 50 g in 1 BOTTLE, PUMP LOTION 50 11 69219-103-02 EXTREME PROTECT SPF 30 1 in 1 BOX LOTION 1 11 69219-103-13 EXTREME PROTECT SPF 30 100 g in 1 BOTTLE, PUMP LOTION 100 11 69219-103-15 EXTREME PROTECT SPF 30 5 g in 1 BOTTLE, PUMP LOTION 5 11 69219-103-28 EXTREME PROTECT SPF 30 240 g in 1 BOTTLE, PUMP LOTION 240 11 69219-103-51 EXTREME PROTECT SPF 30 1 in 1 BOX LOTION 1 11 69219-103-55 EXTREME PROTECT SPF 30 1 in 1 BOX LOTION 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ASIATIC ACID INACTIVE INGREDIENT 9PA5A687X5 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ASIATICOSIDE INACTIVE INGREDIENT PKO39VY215 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 C13-14 ISOPARAFFIN INACTIVE INGREDIENT E4F12ROE70 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ETHYL LINOLEATE INACTIVE INGREDIENT MJ2YTT4J8M EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 LAURETH-7 INACTIVE INGREDIENT Z95S6G8201 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 MADECASSIC ACID INACTIVE INGREDIENT M7O1N24J82 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 OCTYLDODECYL NEOPENTANOATE INACTIVE INGREDIENT X8725R883T EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 OLEA EUROPAEA LEAF INACTIVE INGREDIENT MJ95C3OH47 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 OLEYL ALCOHOL INACTIVE INGREDIENT 172F2WN8DV EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 POLYACRYLAMIDE (1500 MW) INACTIVE INGREDIENT 5D6TC4BRWV EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 PPG-3 MYRISTYL ETHER INACTIVE INGREDIENT 7913J43WZ5 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 SODIUM DIHYDROXYCETYL PHOSPHATE INACTIVE INGREDIENT YWI33EV595 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 VINYLPYRROLIDONE/HEXADECENE COPOLYMER INACTIVE INGREDIENT KFR5QEN0N9 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69219-103 EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC] 10 Current NDC, Legacy NDC, 7 package rows 20250112_ecc4d304-e7e2-45b6-b9b2-2c64d3630860.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 112 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365f3c48-15a6-2d32-e063-6394a90aad78 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365fffa2-b846-7dd3-e063-6394a90a47cb 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Natur LLC 36603550-9c3d-5e33-e063-6394a90adfc9 2025-12-16 Exact identifier application number: M020 Shield And Protect Tinted ZINC OXIDE TRILOGY LABORATORIES, LLC 37f00e51-1123-c04c-e063-6294a90abed8 2025-12-16 Exact identifier application number: M020 Shield And Protect ZINC OXIDE TRILOGY LABORATORIES, LLC 37f09dd5-084f-3c80-e063-6394a90a7a53 2025-12-16 Exact identifier application number: M020 Non Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766496f-231c-f98c-e063-6294a90aae08 2025-12-16 Exact identifier application number: M020 Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766b0d8-20e6-a227-e063-6294a90af4da 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37515807-e29a-3916-e063-6394a90a1ffd 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 374f866d-eb52-61e3-e063-6394a90a77c7 2025-12-16 Exact identifier application number: M020 Tinted Lip Protection TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 3750c23d-c3f8-fac3-e063-6394a90a135e 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 ZINC OXIDE WECARE FRISCO PLLC 374fe86e-cbe8-f911-e063-6294a90a9600 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37507b14-fc01-5e27-e063-6294a90afd50 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 375203a6-2ab8-2a80-e063-6294a90ada72 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 3751caa3-867e-5901-e063-6294a90ab6bd 2025-12-16 Exact identifier application number: M020 Auset Tinted Replenishing Daily Protection ZINC OXIDE SHAYLA BOGER SKIN THERAPY LLC 37da48d6-8f12-ec97-e063-6294a90a699c 2025-12-16 Exact identifier application number: M020 Morning Replenish ZINC OXIDE KATHY JONES AESTHETHICS LLC 37da711e-840b-2f2a-e063-6294a90ab16c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE KATHY JONES AESTHETHICS LLC 37dab729-5988-5eba-e063-6294a90ac6b7 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tory Sullivan, M.D., P.A. 36241e60-f02a-50a7-e063-6394a90a6390 2025-12-16 Exact identifier application number: M020 Ageless All Fitz ZINC OXIDE A.Wall Beauty LLC 37670cb1-ac75-5049-e063-6394a90a4d0a 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Tory Sullivan, M.D., P.A. 36244b27-20e5-f370-e063-6294a90a1f6c 2025-12-16 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 69219-103-01 69219010301 50 g in 1 BOTTLE, PUMP (69219-103-01) 50 g 2026-04-30 No No Current 69219-103-02 69219010302 1 BOTTLE, PUMP in 1 BOX (69219-103-02) / 50 g in 1 BOTTLE, PUMP (69219-103-01) 2026-04-30 No No Current 69219-103-13 69219010313 100 g in 1 BOTTLE, PUMP (69219-103-13) 100 g 2014-10-01 0000-00-00 No No Current 69219-103-15 69219010315 5 g in 1 BOTTLE, PUMP (69219-103-15) 5 g 2014-10-01 0000-00-00 No No Current 69219-103-28 69219010328 240 g in 1 BOTTLE, PUMP (69219-103-28) 240 g 2014-10-01 0000-00-00 No No Current 69219-103-51 69219010351 1 BOTTLE, PUMP in 1 BOX (69219-103-51) / 100 g in 1 BOTTLE, PUMP (69219-103-13) 2014-10-01 0000-00-00 No No Current 69219-103-55 69219010355 1 BOTTLE, PUMP in 1 BOX (69219-103-55) / 5 g in 1 BOTTLE, PUMP (69219-103-15) 2014-10-01 0000-00-00 No No Current