Home NDC 52854-400 Reef Safe SPF 40
Product NDC 52854-400
11-digit product format 528540400
Labeler code 52854
Product ID 52854-400_6ff9e7dd-afe2-40b5-9b41-ec363b621142
Type HUMAN OTC DRUG
Nonproprietary name octocrylene, octisalate, oxybenzone, and avobenzone
Dosage form LOTION
Route TOPICAL
Labeler Tropical Seas, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-07-01
Marketing end 0000-00-00
Substance OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength 4 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52854-400-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52854-400-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52854-400-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52854-400-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52854-400-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52854-400-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52854-400-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52854-400-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52854-400-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52854-400-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52854-400-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52854-400-01 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 avobenzone ACTIVE INGREDIENT G63QQF2NOX REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octisalate ACTIVE INGREDIENT 4X49Y0596W REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octocrylene ACTIVE INGREDIENT 5A68WGF6WM REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 avobenzone ACTIVE MOIETY G63QQF2NOX REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octisalate ACTIVE MOIETY 4X49Y0596W REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 octocrylene ACTIVE MOIETY 5A68WGF6WM REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 oxybenzone ACTIVE MOIETY 95OOS7VE0Y REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 achillea millefolium flower INACTIVE INGREDIENT YQR8R0SQEA REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 althaea officinalis root INACTIVE INGREDIENT TRW2FUF47H REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 american ginseng INACTIVE INGREDIENT 8W75VCV53Q REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 carbomer copolymer type b (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 809Y72KV36 REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 carrageenan INACTIVE INGREDIENT 5C69YCD2YJ REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cetyl dimethicone 150 INACTIVE INGREDIENT 5L694Y0T22 REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 chamomile INACTIVE INGREDIENT FGL3685T2X REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 comfrey root INACTIVE INGREDIENT M9VVZ08EKQ REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 cymbopogon schoenanthus top INACTIVE INGREDIENT 9SJI1LW39W REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 echinacea, unspecified INACTIVE INGREDIENT 4N9P6CC1DX REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 glyceryl stearate se INACTIVE INGREDIENT FCZ5MH785I REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 green tea leaf INACTIVE INGREDIENT W2ZU1RY8B0 REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 high density polyethylene INACTIVE INGREDIENT UG00KM4WR7 REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 lavandula angustifolia flowering top INACTIVE INGREDIENT 9YT4B71U8P REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 macrocystis pyrifera INACTIVE INGREDIENT K31S3OG5C4 REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 phenethyl benzoate INACTIVE INGREDIENT 0C143929GK REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 sambucus nigra flower INACTIVE INGREDIENT 07V4DX094T REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 symphytum uplandicum leaf INACTIVE INGREDIENT D05HXK6R3G REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 taraxacum officinale leaf INACTIVE INGREDIENT 0022LFJ74Y REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 tricontanyl povidone (4 tricontanyl branches/repeat) INACTIVE INGREDIENT N0SS3Q238D REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R REEF SAFE SPF 40 (OCTOCRYLENE, OCTISALATE, OXYBENZONE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 1