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
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	69219-103-13
excluded package	package	69219-103-58
excluded package	package	69219-103-15
excluded package	package	69219-103-28
excluded package	package	69219-103-51
excluded package	package	69219-103-55

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
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ecc4d304-e7e2-45b6-b9b2-2c64d3630860	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ulta Beauty Tinted Moisturizer Cream Spf 24 Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc0ff10-fb2f-e637-e053-6294a90a0c29	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984c64f-eaac-ecb6-e063-6394a90aeb12	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984a014-a56f-753b-e063-6294a90a13f5	2024-12-26	Warnings	Exact identifier application number: M020
Julep No Excuses Gel for Face SPF40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	298404c4-d4be-7395-e063-6294a90a86bf	2024-12-26	Warnings	Exact identifier application number: M020
Cover FX Invisible Primer SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2983dd7c-7ca7-e952-e063-6394a90a3098	2024-12-26	Warnings	Exact identifier application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUM	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	3LAB, INC	2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e	2024-12-26	Warnings	Exact identifier application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	30b224f0-43f1-4c79-839e-3a970e4be3a5	2024-12-26	Warnings	Exact identifier application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN	HOMOSALATE, OCTISALATE, AND AVOBENZONE	CLINIQUE LABORATORIES LLC	f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444	2024-12-25	Warnings	Exact identifier application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ee7e2ded-b850-4e15-96a6-556111e52187	2024-12-25	Warnings	Exact identifier application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d1a3d76f-16dd-4533-8144-9a3175f6e15f	2024-12-25	Warnings	Exact identifier application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15	TITANIUM DIOXIDE	ESTEE LAUDER INC	a04a9aaa-fa0f-4dde-a7a5-c4c561cc51b1	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	ESTEE LAUDER INC	0770e251-95d0-43de-88f1-bc0a29811e4e	2024-12-25	Warnings	Exact identifier application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	MAKEUP ART COSMETICS	c26ef380-1309-4a41-862f-eb319d38673d	2024-12-25	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	ff48435d-245a-4037-9afb-caee83c4c415	2024-12-25	Warnings	Exact identifier application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40	OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	0fe63edf-7a49-4b33-88f1-f480f889d194	2024-12-25	Warnings	Exact identifier application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	8e8c495e-d439-4735-a7cc-b44081b75b27	2024-12-25	Warnings	Exact identifier application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	0fac5204-df18-4774-bb53-115513cb7ff0	2024-12-25	Warnings	Exact identifier application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20	TITANIUM DIOXIDE	MAX HUBER RESEARCH LAB INC	66e48ce0-9a5b-4250-b07b-1622b3814c3e	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	2f93580c-c8e9-4822-91bf-a749cf4deb4e	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cab9-1b3e-e063-6394a90afe5d	2024-12-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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