Home NDC 65121-494-03 Jungle Screen SPF 30
Product NDC 65121-494
Requested package NDC 65121-494-03
11-digit product format 651210494
Labeler code 65121
Product ID 65121-494_48307e03-6b34-2c66-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Pure Source, LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-04-21
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 60 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2020-12-31
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 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 CEDAR LEAF OIL INACTIVE INGREDIENT BJ169U4NLG JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 CETEARYL OLIVATE INACTIVE INGREDIENT 58B69Q84JO JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 CITRONELLA OIL INACTIVE INGREDIENT QYO8Q067D0 JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 ETHYL VANILLIN INACTIVE INGREDIENT YC9ST449YJ JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 GLUCONOLACTONE INACTIVE INGREDIENT WQ29KQ9POT JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 SIMMONDSIA CHINENSIS LEAF INACTIVE INGREDIENT 67G221EK95 JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 SORBITAN OLIVATE INACTIVE INGREDIENT MDL271E3GR JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 VITIS VINIFERA SEED INACTIVE INGREDIENT C34U15ICXA JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 WATERMELON INACTIVE INGREDIENT 231473QB6R JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 WEST INDIAN LEMONGRASS OIL INACTIVE INGREDIENT 5BIA40E9ED JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65121-494-03 65121049403 1 BOTTLE in 1 CARTON (65121-494-03) > 90 mL in 1 BOTTLE 1 bottle 2017-02-10 0000-00-00 No No Current