SHEER FOCUS

Product NDC: 10348-003
11-digit product format: 103480003
Labeler code: 10348
Product ID: 10348-003_886d9244-2d86-4538-9d4a-e799f7e19dc4
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and ZINC OXIDE
Dosage form: LIQUID
Route: TOPICAL
Labeler: SMASHBOX BEAUTY COSMETICS, INC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-06-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; ZINC OXIDE
Active strength: 7 mL/100mL; mL/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10348-003		I	Inactivated by FDA		2026-10-05
excluded package	package	10348-003	10348-003-01	I	Inactivated by FDA		2026-10-05

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10348-003-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10348-003-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10348-003-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10348-003-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10348-003-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10348-003-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10348-003-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10348-003-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10348-003-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10348-003-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10348-003-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10348-003-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10348-003-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10348-003-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10348-003-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10348-003-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10348-003-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10348-003-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10348-003-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10348-003-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10348-003-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10348-003-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10348-003-01	2020-01-31	C162847	48780-1	9d75b9d0-97d8-f424-e053-dadaa90a57ce	SHEER FOCUS TINTED MOISTURIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10348-003-01	SHEER FOCUS TINTED MOISTURIZER	1 in 1 CARTON	LIQUID	1		1
10348-003-01	SHEER FOCUS TINTED MOISTURIZER	50 mL in 1 TUBE	LIQUID	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Alpha-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Betaine	INACTIVE INGREDIENT	3SCV180C9W	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
C20-22 Alcohols	INACTIVE INGREDIENT	O4M0347C6A	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
C20-22 Alkyl Phosphate	INACTIVE INGREDIENT	L4VKP0Y7RP	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Diethylene Glycol Monoethyl Ether	INACTIVE INGREDIENT	A1A1I8X02B	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Honey	INACTIVE INGREDIENT	Y9H1V576FH	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Hydrogenated Soybean Lecithin	INACTIVE INGREDIENT	H1109Z9J4N	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Pectin	INACTIVE INGREDIENT	89NA02M4RX	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Peg-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Phenyl Trimethicone	INACTIVE INGREDIENT	DR0K5NOJ4R	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Potassium Cetyl Phosphate	INACTIVE INGREDIENT	03KCY6P7UT	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Sodium Dehydroacetate	INACTIVE INGREDIENT	8W46YN971G	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Sorbitan Monolaurate	INACTIVE INGREDIENT	6W9PS8B71J	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Squalane	INACTIVE INGREDIENT	GW89575KF9	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Tetrahexyldecyl Ascorbate	INACTIVE INGREDIENT	9LBV3F07AZ	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Triethoxycaprylylsilane	INACTIVE INGREDIENT	LDC331P08E	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10348-003	SHEER FOCUS TINTED MOISTURIZER (OCTINOXATE AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]	1	Legacy NDC, 2 package rows	20120120_7038eba3-a583-498c-9b25-095864343aa7.zip

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	Status
10348-003-01	10348000301	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHEER FOCUS TINTED MOISTURIZER	SMASHBOX BEAUTY COSMETICS, INC \| ELGC Kabushiki Kaisha \| Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) \| ARAMIS, INC \| ESTEE LAUDER COSMETICS DISTRIBUTION CENTER \| ESTEE LAUDER COSMETICS, LTD \| ESTEE LAUDER COSMETICS, LTD. \| ESTEE LAUDER N.V. \| LEN-RON MANUFACTURING DIVISION OF ARAMIS INC \| NORTEC KEYSTONE \| NORTHTEC BRISTOL \| NORTHTEC KEYSTONE \| WHITMAN LABORATORIES, LTD. \| Aveda Corporation \| Northwest Cosmetic Laboratories LLC	2012-01-13	HUMAN OTC DRUG LABEL	1