REEF SAFE SPF 30- octocrylene, octisalate, avobenzone lipstick 
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 5.0%

Octisalate 3.0%

Avobenzone 2.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • helps prevent chapped or cracked skin
  • 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

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

Other Information

  • protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel - Blister Pack Label

Reef Safe

BY TROPICAL SEAS®

UNFLAVORED

Broad Spectrum

SPF 30

LIP BALM

Net Weight .095 oz. (2.81 gm)

Principal Display Panel - Blister Pack Label
REEF SAFE SPF 30 
octocrylene, octisalate, avobenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-796
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LAURYL LAURATE (UNII: GPW77G0937)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
CANDELILLA WAX (UNII: WL0328HX19)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
COCONUT (UNII: 3RT3536DHY)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-796-851 in 1 BLISTER PACK01/01/199506/30/2021
12.81 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/199506/30/2021
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-796)

Revised: 11/2022
Document Id: eea0eb16-d533-7c6e-e053-2a95a90a0241
Set id: e17b20c4-4702-4656-94e0-d5af772b482c
Version: 3
Effective Time: 20221129
 
Tropical Seas, Inc.