REEF SAFE SUN SPF 30 OXYBENZONE FREE- octocrylene, octisalate, and avobenzone spray

Reef Safe Sun SPF 30 Oxybenzone Free by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

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

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, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, vitamin a & d, 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

Biodegradable

Expedition BackCountry™

Reef Safe Sun®

30

Oxybenzone Free Broad Spectrum 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

INGREDIENTS AND APPEARANCE

REEF SAFE SUN SPF 30 OXYBENZONE FREE 
octocrylene, octisalate, and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 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: 52854-132-01	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/14/2018

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-132)