NDC 40046-0036-2 - PREP (plus) PRIME BEAUTY BALM SPF 35

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 40046-0036
Requested NDC: 40046-0036-2
Package NDCs from labels: 40046-0036-2, 40046-0036-1
Manufacturer: MAKE-UP ART COSMETICS | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | PADC 1 | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd.
Effective date: 2010-05-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PREP (plus) PRIME BEAUTY BALM SPF 35	MAKE-UP ART COSMETICS \| ESTEE LAUDER COSMETICS, LTD \| ESTEE LAUDER N.V. \| Len-Ron Manufacturing Division of Aramis Inc. \| Aramis Inc. \| Northtec Bristol \| Northtec Keystone \| PADC 1 \| Estee Lauder Pennsylvania Distribution Center 2 \| Estee Lauder Cosmetics, Ltd. \| Estee Lauder Cosmetics Distribution Center \| Estee Lauder Kabushiki Kaisha \| Whitman Laboratories Ltd.	2010-05-14	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40046-0036-1	2020-01-31	C162847	48780-1	9d75b9d0-5d2e-f424-e053-dadaa90a57ce	390daee0-d16b-466a-81df-c30d130f833d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40046-0036-1	PREP (plus) PRIME BEAUTY BALMSPF 35	1 in 1 CARTON	CREAM	1		1
40046-0036-2	PREP (plus) PRIME BEAUTY BALMSPF 35	30 mL in 1 TUBE	CREAM	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40046-0036	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1	Legacy NDC, 2 package rows	20100720_390daee0-d16b-466a-81df-c30d130f833d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]	1

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 9 of 373 · 7,452 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceile tint PROTECT tinted serum SPF 50 Fair	CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR	LE COSMETICS INC	58545633-cb36-6611-e063-6394a90a1f07	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Light	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT	LE COSMETICS INC	5853ae6b-0eaf-e614-e063-6394a90ae91a	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Light Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM	LE COSMETICS INC	585473c3-3ee9-7d84-e063-6394a90abd33	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM	LE COSMETICS INC	58547b48-251a-10eb-e063-6294a90ac95c	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Medium Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN	LE COSMETICS INC	58547e38-ae84-82ee-e063-6394a90a27d6	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 TAN	LE COSMETICS INC	58548331-38cd-8668-e063-6394a90a3362	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Medium Honey	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY	LE COSMETICS INC	5854861a-376d-8825-e063-6394a90a8aab	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Honey	CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY	LE COSMETICS INC	585488c5-fac5-212f-e063-6294a90a00ff	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Medium Rich	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH	LE COSMETICS INC	585488af-d14f-8d71-e063-6394a90ac4f0	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Rich	CEILE TINT PROTECT TINTED SERUM SPF 50 RICH	LE COSMETICS INC	58548e6d-9c82-249c-e063-6294a90a11ad	2026-08-05	Warnings	Exact identifier unii: SOI2LOH54Z
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY	OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%	Lale Cosmetics LLC	581fb0cd-c55d-d562-e063-6394a90a7f11	2026-08-03	Warnings	Exact identifier unii: SOI2LOH54Z unii: 15FIX9V2JP unii: 4X49Y0596W
Manyo Air Light Moisturizing Sunscreen SPF 50	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Manyo Factory Corp.	86761577-a32c-41a2-a2e3-b339b1493701	2026-08-03	Warnings	Exact identifier unii: 4X49Y0596W
PROCURE	ZINC OXIDE	TWIN MED, LLC	e68ae97e-668e-31c2-e053-2995a90ab4d3	2026-08-03	Warnings	Exact identifier unii: SOI2LOH54Z
EltaMD UV Active	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	39d16479-d491-4c19-aa11-674461687c7b	2026-08-03	Warnings	Exact identifier unii: SOI2LOH54Z unii: 15FIX9V2JP
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30	OCTISALATE, OCTOCRYLENE, AVOBENZONE	AMBI Enterprises LLC	99bbe9a2-bb57-4a33-b339-1649d4b319c8	2026-07-31	Warnings	Exact identifier unii: 4X49Y0596W
AMBI Even and Clear Facial Moisturizer SPF-30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	AMBI Enterprises LLC	4701c0ba-4ceb-4d66-9f99-515ce33b4648	2026-07-31	Warnings	Exact identifier unii: 4X49Y0596W
Continuous Correction Cream	TITANIUM DIOXIDE	Baxter of California, LLC	1cbcc648-f2e1-af60-e063-6294a90ad4bb	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
Continuous Correction Cream	HOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%	Baxter of California, LLC	14b05c8c-0398-2973-e063-6394a90a8a86	2026-07-31	Warnings	Exact identifier unii: 4X49Y0596W
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO GHK-Cu PEPTIDE SUNSCREEN	BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE	Guangdong Aimu Biological Technology Co., Ltd	57a8c34a-d6c9-c03e-e063-6394a90a7af1	2026-07-29	Warnings	Exact identifier unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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