Home NDC 69630-639-01 Soleil Broad Spectrum SPF 30 Sunscreen Body Creme
Product NDC 69630-639
Requested package NDC 69630-639-01
11-digit product format 696300639
Labeler code 69630
Product ID 69630-639_47f5441d-e6d2-0485-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler Soleil Group, LLC
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-25
Marketing end 0000-00-00
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 75 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 · 12 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…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 CITRUS AURANTIIFOLIA FRUIT OIL INACTIVE INGREDIENT 7937R189CB SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 GLUCONOLACTONE INACTIVE INGREDIENT WQ29KQ9POT SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 MICROCRYSTALLINE WAX INACTIVE INGREDIENT XOF597Q3KY SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 MYRRH OIL INACTIVE INGREDIENT H74221J5J4 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 ORANGE PEEL INACTIVE INGREDIENT TI9T76XD44 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 PATCHOULI OIL INACTIVE INGREDIENT F3IN55X5PO SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 ROSA DAMASCENA FLOWER OIL INACTIVE INGREDIENT 18920M3T13 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 SAFFLOWER OIL INACTIVE INGREDIENT 65UEH262IS SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 SALVIA SCLAREA SEED OIL INACTIVE INGREDIENT JK0RP5O3HW SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 SANTALUM SPICATUM OIL INACTIVE INGREDIENT H9LVS6REV4 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 SPEARMINT OIL INACTIVE INGREDIENT C3M81465G5 SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 TETRAHEXYLDECYL ASCORBATE INACTIVE INGREDIENT 9LBV3F07AZ SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 THYME OIL INACTIVE INGREDIENT 2UK410MY6B SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4 WATERMELON INACTIVE INGREDIENT 231473QB6R SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME (OCTINOXATE, TITANIUM DIOXIDE) CREAM [SOLEIL GROUP, LLC] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69630-639-01 69630063901 1 TUBE in 1 BOX (69630-639-01) > 120 mL in 1 TUBE 1 tube 2017-02-07 0000-00-00 No No Current