Reef Safe SPF 30 by Tropical Seas, Inc.

Reef Safe SPF 30 by

Drug Labeling and Warnings

Reef Safe SPF 30 by is a Otc medication manufactured, distributed, or labeled by Tropical Seas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REEF SAFE SPF 30- homosalate, octinoxate, oxybenzone and octisalate spray 
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

Homosalate 10.0%

Octinoxate 6.0%

Oxybenzone 6.0%

Octisalate 2.0%

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

ethanol, 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, acrylates octylacrylamide co-polymer, c12-15 alcohols benzoate, cyclopentasiloxane, octyldodecyl neopentanoate, citronella oil, eucalyptus oil, fir needle oil, lavandin oil, litsea oil, camphor oil, patchouli oil, yara yara, and orange oil.

Other Information

• WARNING: Flammable
  • do not use near open flame or heat source
• hold approximately 10 - 12 inches from skin to spray
• spray into palm of hand, rub together, then apply to your face
• do not spray directly into your face so that it won't get in your eyes.
• rub into skin evenly to ensure appropriate coverage
• 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

BackCountry Tested

Reef Safe®
BY TROPICAL SEAS

30

Original Formula BackCountry SPF 30+

Made with Natural Citronella Oil
to ward off no-see-ums &
other unwanted pests

Water Resistant (80 minutes)

8.45 fl. oz. (250ml) Sprayable Sunscreen

Non-Toxic to Sealife

REEF SAFE SPF 30 
homosalate, octinoxate, oxybenzone and octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CITRONELLA OIL (UNII: QYO8Q067D0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC)
LAVANDIN OIL (UNII: 9RES347CKG)
LITSEA OIL (UNII: 2XIW34BN6O)
CAMPHOR OIL (UNII: 75IZZ8Y727)
PATCHOULI OIL (UNII: F3IN55X5PO)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-032-01	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2010	01/01/2020

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-032)

Revised: 2/2020

Document Id: 9e7a3ff8-8c00-5aae-e053-2995a90a8734

34390-5

Set id: 613b389f-94a1-4dea-b020-4b62439e5cf3

Version: 2

Effective Time: 20200213

 

Tropical Seas, Inc.