REEF SAFE SPF 50- octocrylene, octisalate, oxybenzone, and avobenzone lotion

Reef Safe SPF 50 by

Drug Labeling and Warnings

Reef Safe SPF 50 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 5.0%

Oxybenzone 4.0%

Avobenzone 2.0%

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

Biodegradeable

Reef Safe

By Tropical Seas®

50

Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

4 fl. oz. (120ml) Sunscreen Lotion

Non-Toxic to Sealife

Principal Display Panel - 946 mL Bottle Label

Biodegradable

Reef Safe

By Tropical Seas®

SPF 50+

Water Resistant (80 Minutes)

Broad Spectrum SPF 50+

Sunscreen Lotion

32 fl. oz. (946 ml)

Non-Toxic to Sealife

INGREDIENTS AND APPEARANCE

REEF SAFE SPF 50 
octocrylene, octisalate, oxybenzone, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-500
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	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-500-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2012
2	NDC: 52854-500-02	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2012

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-500)