Jungle Screen SPF 30

Product NDC
65121-494
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65121-494DDiscontinued by firm2026-10-05
excluded packagepackage65121-49465121-494-03DDiscontinued by firm2026-10-05

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65121-494-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65121-494-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65121-494-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65121-494-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65121-494-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65121-494-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65121-494-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65121-494-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65121-494-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65121-494-03ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLGJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JOJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
CITRONELLA OILINACTIVE INGREDIENTQYO8Q067D0JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
ETHYL VANILLININACTIVE INGREDIENTYC9ST449YJJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
SIMMONDSIA CHINENSIS LEAFINACTIVE INGREDIENT67G221EK95JUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXAJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
WATERMELONINACTIVE INGREDIENT231473QB6RJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
WEST INDIAN LEMONGRASS OILINACTIVE INGREDIENT5BIA40E9EDJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VJUNGLE SCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PURE SOURCE INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65121-494-03651210494031 BOTTLE in 1 CARTON (65121-494-03) > 90 mL in 1 BOTTLE1 bottle2017-02-100000-00-00NoNoCurrent