REEF SAFE SPF 30- octinoxate,octisalate, and oxybenzone lotion

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]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

REEF SAFE SPF 30 
octinoxate,octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 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

Inactive Ingredients
Ingredient Name	Strength
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 (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-030-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1995
2	NDC: 52854-030-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1995	12/31/2019
3	NDC: 52854-030-03	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1995	12/31/2019
4	NDC: 52854-030-04	960 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/1995

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-030)