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 182 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer) ZINC OXIDE Brand 2022b LLC 4051ced5-85cf-6211-e063-6394a90a09fc 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen ZINC OXIDE Brand 2022b LLC 4051d241-6890-2b06-e063-6294a90aa09d 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 37 Tinted Moisturizer ZINC OXIDE TITANIUM DIOXIDE Brand 2022b LLC 4052c4e4-2105-80c0-e063-6294a90af41d 2025-10-04 Warnings Exact identifier application number: M020 PLAY Antioxidant Body Mist SPF 50 - Vanilla Orchid AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7a9722-d211-e861-e063-6294a90a6cdc 2025-10-02 Warnings Exact identifier application number: M020 Kids Mineral Sunscreen SPF50 SUNSCREEN Hello Bello 01cc554b-9241-d891-e063-6394a90a8450 2025-10-02 Warnings Exact identifier application number: M020 HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB SUNSCREEN SPF 50 IHerb, LLC 3cab1598-5ef3-df73-e063-6394a90ab1e2 2025-10-01 Warnings Exact identifier application number: M020 Moisturizing Rich Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC 36c3ba26-ca25-7498-e063-6294a90a47fc 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 Shade 1 ZINC OXIDE Dime Beauty Co, LLC 07104cbf-0446-a053-e063-6394a90ab41f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 ZINC OXIDE Dime Beauty Co, LLC 07503a1f-d530-e3bb-e063-6294a90a8ae3 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC e38deed3-e1e2-0b1d-e053-2a95a90a547f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC f2a59fa4-f19c-a15f-e053-2a95a90a6ace 2025-10-01 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414b88ca-a3df-5e42-e063-6294a90a69ba 2025-10-01 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREE ZINC OXIDE KENDO HOLDINGS INC 19120c3f-8fc0-62c3-e063-6394a90a30f3 2025-09-30 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE KENDO HOLDINGS INC 1d26bfb0-3c05-4a0c-9d4b-810359222730 2025-09-30 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER ZINC OXIDE KENDO HOLDINGS INC fd16def1-4c88-3ad0-e053-6294a90ab088 2025-09-30 Warnings Exact identifier application number: M020 FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND ZINC OXIDE KENDO HOLDINGS INC f92b75bd-c5b7-0320-e053-6394a90ab4c3 2025-09-30 Warnings Exact identifier application number: M020 OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30 ZINC OXIDE KENDO HOLDINGS INC f92ae08e-0bca-4775-e053-6394a90ab3d6 2025-09-30 Warnings Exact identifier application number: M020 Sun Kids mineral STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE The Natural SKN Company 400c67aa-55a6-67ea-e063-6294a90a0213 2025-09-30 Warnings Exact identifier application number: M020 toty Ilumina CC Creamy Compact Refill 1C TITANIUM DIOXIDE Chipican LLC f0596830-77ed-11f0-e053-2995a90a8ff5 2025-09-29 Warnings Exact identifier application number: M020 U V-Lamp Shield Mani-Sunscreen ZINC OXIDE, TITANIUM DIOXIDE GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD 3fe7e1c3-e6cd-1420-e063-6394a90a4138 2025-09-28 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 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