Reef Safe SPF 50 description, usages, side effects, indications, overdosage, supplying and lots more!

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Reef Safe SPF 50

Tropical Seas, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Reef Safe SPF 50

octocrylene, octisalate, oxybenzone, and avobenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52854-500
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTOCRYLENE Octocrylene 5 g
OCTISALATE OCTISALATE 5 g
OXYBENZONE OXYBENZONE 4 g
AVOBENZONE AVOBENZONE 2 g

Inactive Ingredients

Ingredient Name Strength
water
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
phenethyl benzoate
STEARIC ACID
GLYCERYL STEARATE SE
CETYL DIMETHICONE 150
GLYCERIN
SODIUM HYDROXIDE
CETOSTEARYL ALCOHOL
POLYSORBATE 60
tricontanyl povidone (4 tricontanyl branches/repeat)
HIGH DENSITY POLYETHYLENE
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETYL ALCOHOL
METHYLPARABEN
DIAZOLIDINYL UREA
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52854-500-01 120 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-07-01


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