Hawaiian Tropic Everyday Active Spf50 Lotion
FDA Label NDC 63354-179

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Edgewell Personal Care Brands Llc for the product Hawaiian Tropic Everyday Active Spf50 (NDC 63354-179). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Active Ingredients
Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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.

Do Not Use

on damaged or broken skin

When Using This Product

do not get into eyes. If contact occurs, rinse thoroughly with water

Stop Use And Ask A Doctor

if irritation or rash develops.

Keep Out Of Reach Of Children.

If 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 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-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Inactive Ingredients

Water, Diisopropyl Adipate, Cetearyl Alcohol,
Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22
Alkyl Methacrylate Copolymer, Fragrance, C12-15 Alkyl Benzoate,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate,
Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum,
Dimethicone, Sodium Hydroxide, Disodium EDTA, Mangifera Indica
(Mango) Seed Butter, Tocopheryl Acetate, Carica Papaya (Papaya)
Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora
Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium
Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice,
Sodium Ascorbyl Phosphate.