Home NDC 65121-682-03 PHACE BIOACTIVE SOOTHING DAY Plus PRIMER BROAD-SPECTRUM SPF 46
Product NDC 65121-682
Requested package NDC 65121-682-03
11-digit product format 651210682
Labeler code 65121
Product ID 65121-682_b6acd64a-fc1f-50c7-e053-2995a90af3c4
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Pure Source, LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-03-19
Marketing end 0000-00-00
Substance OCTINOXATE; ZINC OXIDE
Active strength 75 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 10 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…
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 Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 CYCLOMETHICONE 4 INACTIVE INGREDIENT CZ227117JE PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 HYALURONIC ACID INACTIVE INGREDIENT S270N0TRQY PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 LOWBUSH BLUEBERRY INACTIVE INGREDIENT G90PX41VP0 PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 PROPANEDIOL INACTIVE INGREDIENT 5965N8W85T PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 PUNICA GRANATUM ROOT BARK INACTIVE INGREDIENT CLV24I3T1D PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 VITIS VINIFERA SEED INACTIVE INGREDIENT C34U15ICXA PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PHACE BIOACTIVE SOOTHING DAY PLUS PRIMER BROAD-SPECTRUM SPF 46 (OCTINOXATE, ZINC OXIDE) LOTION [PURE SOURCE, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65121-682-03 65121068203 1 BOTTLE, PUMP in 1 PACKAGE (65121-682-03) > 50 mL in 1 BOTTLE, PUMP 2017-02-10 0000-00-00 No No Current