Home NDC 52854-045-01 Reef Safe SPF 45
Product NDC 52854-045
Requested package NDC 52854-045-01
11-digit product format 528540045
Labeler code 52854
Product ID 52854-045_9ce5d8f3-b8d7-b83f-e053-2995a90a01e2
Type HUMAN OTC DRUG
Nonproprietary name octocrylene, octinoxate, oxybenzone, homosalate and octisalate
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 OCTOCRYLENE; OCTINOXATE; OXYBENZONE; HOMOSALATE; OCTISALATE
Active strength 8 g/100mL; g/100mL; 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 homosalate ACTIVE INGREDIENT V06SV4M95S REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 octisalate ACTIVE INGREDIENT 4X49Y0596W REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 octocrylene ACTIVE INGREDIENT 5A68WGF6WM REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 homosalate ACTIVE MOIETY V06SV4M95S REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 octinoxate ACTIVE MOIETY 4Y5P7MUD51 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 octisalate ACTIVE MOIETY 4X49Y0596W REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 octocrylene ACTIVE MOIETY 5A68WGF6WM REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 oxybenzone ACTIVE MOIETY 95OOS7VE0Y REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 achillea millefolium flower INACTIVE INGREDIENT YQR8R0SQEA REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 althaea officinalis root INACTIVE INGREDIENT TRW2FUF47H REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 american ginseng INACTIVE INGREDIENT 8W75VCV53Q REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 carbomer copolymer type b (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 809Y72KV36 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 carrageenan INACTIVE INGREDIENT 5C69YCD2YJ REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 cetyl dimethicone 150 INACTIVE INGREDIENT 5L694Y0T22 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 chamomile INACTIVE INGREDIENT FGL3685T2X REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 comfrey root INACTIVE INGREDIENT M9VVZ08EKQ REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 cymbopogon schoenanthus top INACTIVE INGREDIENT 9SJI1LW39W REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 echinacea, unspecified INACTIVE INGREDIENT 4N9P6CC1DX REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 glyceryl stearate se INACTIVE INGREDIENT FCZ5MH785I REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 green tea leaf INACTIVE INGREDIENT W2ZU1RY8B0 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 high density polyethylene INACTIVE INGREDIENT UG00KM4WR7 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 lavandula angustifolia flowering top INACTIVE INGREDIENT 9YT4B71U8P REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 macrocystis pyrifera INACTIVE INGREDIENT K31S3OG5C4 REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 sambucus nigra flower INACTIVE INGREDIENT 07V4DX094T REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 symphytum uplandicum leaf INACTIVE INGREDIENT D05HXK6R3G REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 taraxacum officinale leaf INACTIVE INGREDIENT 0022LFJ74Y REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 tricontanyl povidone (4 tricontanyl branches/repeat) INACTIVE INGREDIENT N0SS3Q238D REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R REEF SAFE SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) 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 52854-045-01 52854004501 120 mL in 1 BOTTLE, PLASTIC (52854-045-01) 120 ml 1995-01-01 0000-00-00 No No Current