PREP AND PRIME

Product NDC: 40046-0039
11-digit product format: 400460039
Labeler code: 40046
Product ID: 40046-0039_8e82c4a4-fbc9-46bb-980e-31e302be7f7a
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE
Dosage form: CREAM
Route: TOPICAL
Labeler: MAKEUP ART COSMETICS
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-04-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE; TITANIUM DIOXIDE
Active strength: 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40046-0039-1	2020-01-31	C162847	48780-1	9d75b9d0-0550-f424-e053-dadaa90a57ce	a1b22e6f-5dde-48b0-86f2-305b1bc67c0c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40046-0039-1	PREP AND PRIMEFORTIFIED SKIN ENHANCER SPF 35	1 in 1 CARTON	CREAM	1		1
40046-0039-2	PREP AND PRIMEFORTIFIED SKIN ENHANCER SPF 35	30 mL in 1 TUBE	CREAM	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
BARLEY	INACTIVE INGREDIENT	5PWM7YLI7R	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
CAFFEINE	INACTIVE INGREDIENT	3G6A5W338E	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
ENOXOLONE	INACTIVE INGREDIENT	P540XA09DR	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
GAMMA ORYZANOL	INACTIVE INGREDIENT	SST9XCL51M	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
OCTYLDODECYL STEAROYL STEARATE	INACTIVE INGREDIENT	3D47Q6D93C	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)	INACTIVE INGREDIENT	255PIF62MS	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
POLYMETHYLSILSESQUIOXANE (11 MICRONS)	INACTIVE INGREDIENT	Z570VEV8XK	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
SODIUM STEAROYL LACTYLATE	INACTIVE INGREDIENT	IN99IT31LN	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
WHEAT GERM	INACTIVE INGREDIENT	YR3G369F5A	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40046-0039	PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE) CREAM [MAKEUP ART COSMETICS]	1	Legacy NDC, 2 package rows	20110715_a1b22e6f-5dde-48b0-86f2-305b1bc67c0c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
40046-0039-1	40046003901	1 in 1 CARTON		Historical
40046-0039-2	40046003902	30 mL in 1 TUBE	30 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35	MAKEUP ART COSMETICS \| ESTEE LAUDER COSMETICS, LTD \| ESTEE LAUDER N.V. \| Len-Ron Manufacturing Division of Aramis Inc. \| Aramis Inc. \| Northtec Bristol \| Northtec Keystone \| Estee Lauder Pennsylvania Distribution Center 2 \| Estee Lauder Cosmetics, Ltd. \| Estee Lauder Cosmetics Distribution Center \| Estee Lauder Kabushiki Kaisha \| Whitman Laboratories Ltd. \| Aveda Corporation	2011-07-14	HUMAN OTC DRUG LABEL	1

PREP AND PRIME

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#