Home NDC 52854-015-01 Reef Safe SPF 15
Product NDC 52854-015
Requested package NDC 52854-015-01
11-digit product format 528540015
Labeler code 52854
Product ID 52854-015_9e65f32d-ab16-404b-e053-2995a90adc1b
Type HUMAN OTC DRUG
Nonproprietary name octinoxate,octisalate, and oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Tropical Seas, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1995-01-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 7 g/100mL; g/100mL; g/100mL
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octisalate ACTIVE INGREDIENT 4X49Y0596W REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octinoxate ACTIVE MOIETY 4Y5P7MUD51 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octisalate ACTIVE MOIETY 4X49Y0596W REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 oxybenzone ACTIVE MOIETY 95OOS7VE0Y REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 achillea millefolium flower INACTIVE INGREDIENT YQR8R0SQEA REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 althaea officinalis root INACTIVE INGREDIENT TRW2FUF47H REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 american ginseng INACTIVE INGREDIENT 8W75VCV53Q REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 carbomer copolymer type b (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 809Y72KV36 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 carrageenan INACTIVE INGREDIENT 5C69YCD2YJ REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cetyl dimethicone 150 INACTIVE INGREDIENT 5L694Y0T22 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 chamomile INACTIVE INGREDIENT FGL3685T2X REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 comfrey root INACTIVE INGREDIENT M9VVZ08EKQ REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cymbopogon schoenanthus top INACTIVE INGREDIENT 9SJI1LW39W REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 echinacea, unspecified INACTIVE INGREDIENT 4N9P6CC1DX REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 glyceryl stearate se INACTIVE INGREDIENT FCZ5MH785I REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 green tea leaf INACTIVE INGREDIENT W2ZU1RY8B0 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 high density polyethylene INACTIVE INGREDIENT UG00KM4WR7 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 lavandula angustifolia flowering top INACTIVE INGREDIENT 9YT4B71U8P REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 macrocystis pyrifera INACTIVE INGREDIENT K31S3OG5C4 REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 sambucus nigra flower INACTIVE INGREDIENT 07V4DX094T REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 symphytum uplandicum leaf INACTIVE INGREDIENT D05HXK6R3G REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 taraxacum officinale leaf INACTIVE INGREDIENT 0022LFJ74Y REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 tricontanyl povidone (4 tricontanyl branches/repeat) INACTIVE INGREDIENT N0SS3Q238D REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R REEF SAFE SPF 15 (OCTINOXATE,OCTISALATE, AND OXYBENZONE) LOTION [TROPICAL SEAS, 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 52854-015-01 52854001501 120 mL in 1 BOTTLE, PLASTIC (52854-015-01) 120 ml 1995-01-01 0000-00-00 No No Current