Indications and uses
helps prevent sunburn
Reef Safe SPF 36
- Manufacturer
- Tropical Seas, Inc.
- Effective date
- 2020-02-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:41:38
Label at a glance#
ProductReef Safe SPF 36
Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE, HOMOSALATE
Label structure10 sections
Dosage and administration
apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
Octinoxate 7.5%
Oxybenzone 6.0%
Octisalate 5.0%
Homosalate 4.0%
Purpose
Sunscreen
Uses
- helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.
For external use only
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor
Inactive Ingredients
aqueous extracts of: aloe barbadensis leaf extract, algea extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root and leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, camellia sinensis (white tea) extract, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), titanium dioxide, cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, methylparaben, cetyl alcohol (vegetable derived), diazolidinyl urea and propylparaben.
Other Information
- protect this product from excessive heat and direct sun
Questions or comments?
Call toll free 1-800-368-7327
Principal Display Panel - Bottle Label
Biodegradeable
Reef Safe
BY TROPICAL SEAS
®
SPF36+ Bait Safe Off Shore Sport
Original Formula
Water Resistant (80 minutes)
Sunscreen Lotion
4 fl. oz. (120ml)
Non-Toxic to Sealife
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52854-036-01 | 2022-11-29 | C162847 | 48780-1 | d6a99b39-bb1f-a426-e053-dadaa90af4c2 | ade7f576-8663-4804-a16b-502a8ccc881f |
| 52854-036-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-bb1f-a426-e053-dadaa90af4c2 | ade7f576-8663-4804-a16b-502a8ccc881f |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| homosalate | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| homosalate | ACTIVE MOIETY | V06SV4M95S | 1 | |
| octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| achillea millefolium flower | INACTIVE INGREDIENT | YQR8R0SQEA | 1 | |
| aloe vera leaf | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| althaea officinalis root | INACTIVE INGREDIENT | TRW2FUF47H | 1 | |
| american ginseng | INACTIVE INGREDIENT | 8W75VCV53Q | 1 | |
| carbomer copolymer type b (allyl pentaerythritol crosslinked) | INACTIVE INGREDIENT | 809Y72KV36 | 1 | |
| carrageenan | INACTIVE INGREDIENT | 5C69YCD2YJ | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cetyl dimethicone 150 | INACTIVE INGREDIENT | 5L694Y0T22 | 1 | |
| chamomile | INACTIVE INGREDIENT | FGL3685T2X | 1 | |
| comfrey root | INACTIVE INGREDIENT | M9VVZ08EKQ | 1 | |
| cymbopogon schoenanthus top | INACTIVE INGREDIENT | 9SJI1LW39W | 1 | |
| diazolidinyl urea | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| echinacea, unspecified | INACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl stearate se | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| green tea leaf | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| high density polyethylene | INACTIVE INGREDIENT | UG00KM4WR7 | 1 | |
| lavandula angustifolia flowering top | INACTIVE INGREDIENT | 9YT4B71U8P | 1 | |
| macrocystis pyrifera | INACTIVE INGREDIENT | K31S3OG5C4 | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| sambucus nigra flower | INACTIVE INGREDIENT | 07V4DX094T | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| symphytum uplandicum leaf | INACTIVE INGREDIENT | D05HXK6R3G | 1 | |
| taraxacum officinale leaf | INACTIVE INGREDIENT | 0022LFJ74Y | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| tricontanyl povidone (4 tricontanyl branches/repeat) | INACTIVE INGREDIENT | N0SS3Q238D | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Reef Safe SPF 36
- octinoxate, oxybenzone, octisalate, and homosalate
- WATER
- ALOE VERA LEAF
- CARRAGEENAN
- CHAMOMILE
- SYMPHYTUM UPLANDICUM LEAF
- COMFREY ROOT
- TARAXACUM OFFICINALE LEAF
- ECHINACEA, UNSPECIFIED
- SAMBUCUS NIGRA FLOWER
- AMERICAN GINSENG
- MACROCYSTIS PYRIFERA
- LAVANDULA ANGUSTIFOLIA FLOWERING TOP
- CYMBOPOGON SCHOENANTHUS TOP
- ALTHAEA OFFICINALIS ROOT
- ACHILLEA MILLEFOLIUM FLOWER
- GREEN TEA LEAF
- STEARIC ACID
- GLYCERYL STEARATE SE
- TITANIUM DIOXIDE
- CETYL DIMETHICONE 150
- GLYCERIN
- SODIUM HYDROXIDE
- CETOSTEARYL ALCOHOL
- POLYSORBATE 60
- TRICONTANYL POVIDONE
- HIGH DENSITY POLYETHYLENE
- CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- METHYLPARABEN
- CETYL ALCOHOL
- DIAZOLIDINYL UREA
- PROPYLPARABEN
- OCTINOXATE
- OXYBENZONE
- OCTISALATE
- HOMOSALATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52854-036 | 52854-036-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | TABLET, COATED / ORAL | NA | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACARDIAC | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT / TOPICAL | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASPINAL | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| diazolidinyl urea | DIAZOLIDINYL UREA | H5RIZ3MPW4 | OINTMENT / TOPICAL | 0.1 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / NASAL | 20 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| high density polyethylene | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | GEL / TOPICAL | 26 %w/w | ||
| glyceryl stearate se | GLYCERYL STEARATE SE | FCZ5MH785I | CREAM / TOPICAL | 4 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SWAB / TOPICAL | 0.01 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / RECTAL | 0.05 mg/mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRA-ARTICULAR | ADJ PH | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRATHECAL | ADJ PH | ||
| carbomer copolymer type b (allyl pentaerythritol crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | CREAM / TOPICAL | 2 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAVASCULAR | ADJ PH | ||
| glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| carbomer copolymer type b (allyl pentaerythritol crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | GEL / TOPICAL | 150 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| eea03128-5cda-9c4f-e053-2995a90ac7e4 | ade7f576-8663-4804-a16b-502a8ccc881f | 2022-11-29 | Warnings | ade7f576-8663-4804-a16b-502a8ccc881f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.