REEF SAFE SPF 20- octocrylene, octisalate, and avobenzone lotion 
Tropical Seas, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Octocrylene 3.0%

Octisalate 2.0%

Avobenzone 1.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & 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, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol (vegetable derived), methylparaben, 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 - 120 mL Bottle Label

Biodegradable

Reef Safe

By Tropical Seas®

Oxybenzone Free

20

Broad Spectrum SPF 20+

Water Resistant (80 Minutes)

4 fl. oz. (120ml) Sunscreen Lotion

Non-Toxic to Sealife

Principal Display Panel - 120 mL Bottle Label


REEF SAFE SPF 20 
octocrylene, octisalate, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CHAMOMILE (UNII: FGL3685T2X)  
SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
AMERICAN GINSENG (UNII: 8W75VCV53Q)  
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-200-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201206/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/201206/30/2021
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-200)

Revised: 11/2022
Document Id: eea09f90-a74b-7b8d-e053-2a95a90a57ce
Set id: 3c941437-4e56-4114-a464-1d8b8865dbb4
Version: 4
Effective Time: 20221129
 
Tropical Seas, Inc.