SUN THERAPE BODY

Product NDC: 67879-303
Requested package NDC: 67879-303-51
11-digit product format: 678790303
Labeler code: 67879
Product ID: 67879-303_cf5c46ba-4839-0850-e053-2995a90a7ec4
Type: HUMAN OTC DRUG
Nonproprietary name: HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: PHARMAGEL INTERNATIONAL INC
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-06-18
Marketing end: 0000-00-00
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength: 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67879-303	67879-303-51	D	Discontinued by firm		2026-10-12

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
ACHILLEA MILLEFOLIUM	INACTIVE INGREDIENT	2FXJ6SW4PK	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
BORAGE OIL	INACTIVE INGREDIENT	F8XAG1755S	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
CHONDRUS CRISPUS	INACTIVE INGREDIENT	OQS23HUA1X	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
DEANOL BITARTRATE	INACTIVE INGREDIENT	D240J05W14	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
ECHINACEA ANGUSTIFOLIA	INACTIVE INGREDIENT	VB06AV5US8	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
HYDROGENATED SOYBEAN LECITHIN	INACTIVE INGREDIENT	H1109Z9J4N	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
LIMONIUM GERBERI WHOLE	INACTIVE INGREDIENT	2J5K7YCF9F	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
MAGNESIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	0R822556M5	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
PEG-7 GLYCERYL COCOATE	INACTIVE INGREDIENT	VNX7251543	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
ROSA CANINA FRUIT	INACTIVE INGREDIENT	3TNW8D08V3	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
STARCH, TAPIOCA	INACTIVE INGREDIENT	24SC3U704I	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUN THERAPE BODY SPF-35 (HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67879-303-51	67879030351	1 TUBE in 1 BOX (67879-303-51) > 175 mL in 1 TUBE (67879-303-11)	1 tube	2015-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHARMAGEL - SUN THERAPE BODY LOTION (67879-303)	PHARMAGEL INTERNATIONAL INC	2024-08-13	HUMAN OTC DRUG LABEL	8

SUN THERAPE BODY

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#