HAWAIIAN TROPIC- avobenzone octisalate octocrylene oil

HAWAIIAN TROPIC by

Drug Labeling and Warnings

HAWAIIAN TROPIC by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%, Octisalate 2.5%, Octocrylene 3.0%

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

May stain some fabrics and surfaces.

Do not use on

damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop 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 two hours Sun Protection Measures. Spending time in the sun with a broad spectrum SPF of 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

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Aloe Barbadensis Leaf Extract, Red 17, Yellow 11.

Other Information

protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN
TROPIC®
SUNSCREEN OIL SPRAY
PROTECTIVE
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 15 UVA/UVB
WATER RESISTANT (80 MINUTES
8 FL. OZ (236 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone octisalate octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
D&C RED NO. 17 (UNII: ND733RX3JN)
COCOA BUTTER (UNII: 512OYT1CRR)
CORN OIL (UNII: 8470G57WFM)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
TARTARIC ACID (UNII: W4888I119H)
CARROT (UNII: L56Z1JK48B)
HISTIDINE (UNII: 4QD397987E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
PAPAYA (UNII: KU94FIY6JB)
MINERAL OIL (UNII: T5L8T28FGP)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL OLEATE (UNII: 4PC054V79P)
BETA CAROTENE (UNII: 01YAE03M7J)
GUAVA (UNII: 74O70D6VG0)
MANGO (UNII: I629I3NR86)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ARGININE (UNII: 94ZLA3W45F)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-319-16	236 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/30/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)