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 247 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	06ab109e-abcf-0861-e063-6394a90a9375	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d3379ba-465d-a889-e063-6394a90aaf23	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d339273-6d82-0979-e063-6394a90a3de7	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0cc97b34-e9e6-ef6a-e063-6394a90aee89	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0cc9760b-b88b-f291-e063-6294a90a242f	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d338ec2-dca0-e032-e063-6394a90a69aa	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0752d79d-5d82-0367-e063-6394a90a4f1c	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d33888d-20b3-f912-e063-6394a90a25dc	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d3379ba-465c-a889-e063-6394a90aaf23	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b25290-33a0-bafd-e063-6394a90a7a94	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0751b356-607f-f3cb-e063-6294a90a4092	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cace-1b3e-e063-6394a90afe5d	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	07530636-cd21-3022-e063-6394a90a89d6	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0752753e-cac9-9166-e063-6394a90a4d8d	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06ad3c09-9f1b-b25c-e063-6294a90aebe1	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c57ff5-7013-d35f-e063-6394a90a6ee2	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b1f8bc-8b29-451a-e063-6294a90a34bd	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44de-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44ef-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b25290-33a3-bafd-e063-6394a90a7a94	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