FDA.reportPublic FDA data

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.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69219-103-13
excluded packagepackage69219-103-58
excluded packagepackage69219-103-15
excluded packagepackage69219-103-28
excluded packagepackage69219-103-51
excluded packagepackage69219-103-55

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
IngredientStrength
OCTINOXATE5.5 g/100g
ZINC OXIDE4.12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ecc4d304-e7e2-45b6-b9b2-2c64d3630860Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69219-103-01EXTREME PROTECT SPF 3050 g in 1 BOTTLE, PUMPLOTION5011
69219-103-02EXTREME PROTECT SPF 301 in 1 BOXLOTION111
69219-103-13EXTREME PROTECT SPF 30100 g in 1 BOTTLE, PUMPLOTION10011
69219-103-15EXTREME PROTECT SPF 305 g in 1 BOTTLE, PUMPLOTION511
69219-103-28EXTREME PROTECT SPF 30240 g in 1 BOTTLE, PUMPLOTION24011
69219-103-51EXTREME PROTECT SPF 301 in 1 BOXLOTION111
69219-103-55EXTREME PROTECT SPF 301 in 1 BOXLOTION111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ASIATIC ACIDINACTIVE INGREDIENT9PA5A687X5EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ASIATICOSIDEINACTIVE INGREDIENTPKO39VY215EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ETHYL LINOLEATEINACTIVE INGREDIENTMJ2YTT4J8MEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
MADECASSIC ACIDINACTIVE INGREDIENTM7O1N24J82EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883TEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999REXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVEXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
PPG-3 MYRISTYL ETHERINACTIVE INGREDIENT7913J43WZ5EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
SODIUM DIHYDROXYCETYL PHOSPHATEINACTIVE INGREDIENTYWI33EV595EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
VINYLPYRROLIDONE/HEXADECENE COPOLYMERINACTIVE INGREDIENTKFR5QEN0N9EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1
WATERINACTIVE INGREDIENT059QF0KO0REXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69219-103EXTREME PROTECT SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SCIENCE OF SKINCARE LLC]10Current NDC, Legacy NDC, 7 package rows20250112_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 235 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen UnscentedZINC OXIDEEco Lips, Inc.febabad6-0bf2-a3f8-e053-6294a90a3aeb2025-01-08WarningsExact identifier
application number: M020
LESS EVERY TONE SPF 30ZINC OXIDEHappy Farm Botanicals, Inc.e91ded4b-987d-17a8-e053-2995a90adc2e2025-01-08WarningsExact identifier
application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact identifier
application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
application number: M020
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self TannerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.4d58de8e-875b-4b77-b0ef-b9d760aaced82025-01-07WarningsExact identifier
application number: M020
Pop Zinc SunscreenZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd2b29ddb2-5730-8a67-e063-6394a90ae4162025-01-07WarningsExact identifier
application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLCbbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c22025-01-07WarningsExact identifier
application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATEMedik8 Limited29071920-ba90-871a-e063-6294a90aee272025-01-06WarningsExact identifier
application number: M020
Dimples Bath Co - Sunstick New Kid On The BlockZINC OXIDEDimples Bath Co. LLC26f682f4-2440-f111-e063-6294a90ab4b72025-01-06WarningsExact identifier
application number: M020
Diaper Rash Cream Happy CheeksDIAPER RASH HAPPY CHEEKSDimples Bath Co. LLC26cef2eb-a133-11ec-e063-6394a90a0f082025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26fec959-c234-6692-e063-6394a90a66002025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26f85758-820f-3f73-e063-6294a90a289d2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Face MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0f0b56-233f-4c6a-e063-6394a90aea6f2025-01-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69219-103-016921901030150 g in 1 BOTTLE, PUMP (69219-103-01) 50 g2026-04-30NoNoCurrent
69219-103-02692190103021 BOTTLE, PUMP in 1 BOX (69219-103-02) / 50 g in 1 BOTTLE, PUMP (69219-103-01) 2026-04-30NoNoCurrent
69219-103-1369219010313100 g in 1 BOTTLE, PUMP (69219-103-13) 100 g2014-10-010000-00-00NoNoCurrent
69219-103-15692190103155 g in 1 BOTTLE, PUMP (69219-103-15) 5 g2014-10-010000-00-00NoNoCurrent
69219-103-2869219010328240 g in 1 BOTTLE, PUMP (69219-103-28) 240 g2014-10-010000-00-00NoNoCurrent
69219-103-51692190103511 BOTTLE, PUMP in 1 BOX (69219-103-51) / 100 g in 1 BOTTLE, PUMP (69219-103-13) 2014-10-010000-00-00NoNoCurrent
69219-103-55692190103551 BOTTLE, PUMP in 1 BOX (69219-103-55) / 5 g in 1 BOTTLE, PUMP (69219-103-15) 2014-10-010000-00-00NoNoCurrent