HAWAIIAN TROPIC description, usages, side effects, indications, overdosage, supplying and lots more!

HAWAIIAN TROPIC

Energizer Personal Care LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Oxybenzone 2.0%
Avobenzone 2.0%
Octocrylene 2.0%

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 only 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.

May stain some fabrics.

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

Water, Ethylhexyl Benzoate, Glycerin, VP/Eicosene Copolymer, Cetearyl Alcohol, Diisopropyl Adipate, Isopropyl Myristate, Isopropyl Palmitate, Phenethyl Benzoate, Polymethylsilsesquioxane, Polyethylene, Sodium Polyacrylate, Caprylyl Glycol, Dimethicone, Coco-Glucoside, Ceteth-10 Phosphate, Dicetyl Phosphate, Xanthan Gum, Disodium EDTA, Paraffin, Mica, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Silk Amino Acids, Panthenol, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance, Bismuth Oxychloride, Iron Oxides.

Other Information

  • protect this product from excessive heat and direct sun

Questions or Comments?

1-800-NO UV RAY, Mon-Fri

Principle Display Panel

HAWAIIAN Tropic

Silk HYDRATION

Lotion Sunscreen

BROAD SPECTRUM

SPF 12

12

12 HOUR Moisturization *

with hydrating ribbons

6 FL. OZ. (177 mL)

Principle Display Panel

HAWAIIAN TROPIC

OXYBENZONE, AVOBENZONE, OCTOCRYLENE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63354-615
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXYBENZONE OXYBENZONE 2 g
AVOBENZONE AVOBENZONE 2 g
OCTOCRYLENE Octocrylene 2 g

Inactive Ingredients

Ingredient Name Strength
water
2-ETHYLHEXYL BENZOATE
GLYCERIN
CETOSTEARYL ALCOHOL
DIISOPROPYL ADIPATE
ISOPROPYL MYRISTATE
ISOPROPYL PALMITATE
phenethyl benzoate
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
HIGH DENSITY POLYETHYLENE
SODIUM POLYACRYLATE (2500000 MW)
CAPRYLYL GLYCOL
DIMETHICONE
COCO GLUCOSIDE
CETETH-10 PHOSPHATE
DIHEXADECYL PHOSPHATE
XANTHAN GUM
EDETATE DISODIUM
PARAFFIN
MICA
SHEA BUTTER
Mangifera Indica Seed Butter
AMINO ACIDS, SILK
PANTHENOL
SODIUM ASCORBYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
PAPAYA
COLOCASIA ESCULENTA ROOT
MANGO
PASSIFLORA INCARNATA FRUIT
GUAVA
PHENOXYETHANOL
METHYLPARABEN
PROPYLPARABEN
BISMUTH OXYCHLORIDE
FERRIC OXIDE YELLOW
ferric oxide red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63354-615-54 177 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-12-03


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