Drug Labeling and Warnings

Drug Details

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REEF SAFE SPF 30 - octinoxate,octisalate, and oxybenzone 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

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 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

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
  • 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
®

SPF30+

Original Formula

Water Resistant (80 minutes)

Sunscreen Lotion

4 fl. oz. (120ml)

Non-Toxic to Sealife

Principal Display Panel - Bottle Label


REEF SAFE SPF 30 
octinoxate,octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52854-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate7.5 g  in 100 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate5 g  in 100 mL
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone4 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)  
stearic acid (UNII: 4ELV7Z65AP)  
glyceryl stearate se (UNII: FCZ5MH785I)  
titanium dioxide (UNII: 15FIX9V2JP)  
cetyl dimethicone 150 (UNII: 5L694Y0T22)  
glycerin (UNII: PDC6A3C0OX)  
sodium hydroxide (UNII: 55X04QC32I)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
polysorbate 60 (UNII: CAL22UVI4M)  
tricontanyl povidone (4 tricontanyl branches/repeat) (UNII: N0SS3Q238D)  
high density polyethylene (UNII: UG00KM4WR7)  
carbomer copolymer type b (allyl pentaerythritol crosslinked) (UNII: 809Y72KV36)  
methylparaben (UNII: A2I8C7HI9T)  
cetyl alcohol (UNII: 936JST6JCN)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
propylparaben (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52854-030-01120 mL in 1 BOTTLE, PLASTIC
2NDC: 52854-030-0260 mL in 1 BOTTLE, PLASTIC
3NDC: 52854-030-0315 mL in 1 BOTTLE, PLASTIC
4NDC: 52854-030-04960 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/1995
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-030)

Revised: 3/2014
 
Tropical Seas, Inc.


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