Reef Safe SPF 45 description, usages, side effects, indications, overdosage, supplying and lots more!

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Reef Safe SPF 45

Tropical Seas, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Homosalate 10.0%

Octylcrylene 10.0%

Octinoxate 7.5%

Oxybenzone 6.0%

Octisalate 5.0%

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, and fragrance.

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

Reef Safe ®
BY TROPICAL SEAS

45

Original Formula SPF 45+

Water Resistant (80 minutes)

8.45 fl. oz. (250ml) Sprayable Sunscreen

Non-Toxic to Sealife

Reef Safe SPF 45

homosalate, octocrylene, octinoxate, oxybenzone and octisalate SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52854-046
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 10 g
OCTOCRYLENE Octocrylene 10 g
OCTINOXATE OCTINOXATE 7.5 g
OXYBENZONE OXYBENZONE 6 g
OCTISALATE OCTISALATE 5 g

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
Aloe Vera Leaf
CARRAGEENAN
CHAMOMILE
symphytum uplandicum leaf
COMFREY ROOT
TARAXACUM OFFICINALE LEAF
ECHINACEA, UNSPECIFIED
SAMBUCUS NIGRA FLOWER
AMERICAN GINSENG
MACROCYSTIS PYRIFERA
LAVANDULA ANGUSTIFOLIA FLOWERING TOP
cymbopogon schoenanthus top
ALTHAEA OFFICINALIS ROOT
ACHILLEA MILLEFOLIUM FLOWER
GREEN TEA LEAF
ALKYL (C12-15) BENZOATE
CYCLOMETHICONE 5
OCTYLDODECYL NEOPENTANOATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52854-046-01 250 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-01-01


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