Hawaiian Tropic Sunscreen Sheer Touch Spf 70 Lotion
FDA Label NDC 63354-386

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 Sunscreen Sheer Touch Spf 70 (NDC 63354-386). 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, when using this product, do not use, stop 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

→ When Using This Product

→ Do Not Use

→ Stop And Ask A Doctor

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Avobenzone 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 8.5%.

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

When Using This Product

keep out of eyes. Rinse with water to remove.

Do Not Use

on damaged or broken skin

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 increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value 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, Ethylhexyl Methoxycrylene, Glycerin, Phenoxyethanol, VP/Eicosene Copolymer, Mica, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco Glucoside, Chlorphenesin, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butyrospermum Parkii (Shea) Butter, Sodium Hydroxide, Disodium EDTA, Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica
(Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Sodium Ascorbyl Phosphate, Titanium Dioxide.