Drug labels

Broad Spectrum SPF 30 Tropical Sunscreen

BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN · Raining Rose, Inc · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
18e7fc6b-b40a-f790-e063-6294a90ad0f4
ID
18e7fc6b-b40b-f790-e063-6294a90ad0f4
Effective time
20240520
Version
1
SPL product data elements

Broad Spectrum SPF 30 Tropical Sunscreen Broad Spectrum SPF 30 Tropical Sunscreen OCTISALATE OCTISALATE GLYCERIN SOYBEAN OIL ALOE VERA LEAF POTASSIUM SORBATE TOCOPHEROL WATER AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL GRAPE SEED OIL SUNFLOWER OIL XANTHAN GUM PENTYLENE GLYCOL ALMOND OIL ANHYDROUS CITRIC ACID HOMOSALATE HOMOSALATE BENZYL ALCOHOL GLYCERYL STEARATE SE PROPANEDIOL

Active ingredient
Active Ingredients: Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%
Purpose
Sunscreen
Indications and usage
Helps prevent sunburn
Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours Children under 6 months of age: Ask a doctor 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 sunprotection measures including: limit time in the sun, especially from 10a.m.-2p.m. wear long sleeved shirts, pants, hats and sunglasses.

Other safety information
Protect this product from excessive heat and direct sun.
Inactive ingredient

Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Glycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Almond Oil, Tocopherol, Water, Xanthan Gum.

Package label principal display panel
C11087 4Imprint 1floz spf 30 bs tropical SS
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Broad Spectrum SPF 30 Tropical Sunscreen
Generic name
BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN
Manufacturer name
Raining Rose, Inc
Product NDC
65692-0577
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
OCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
SPL ID
18e7fc6b-b40b-f790-e063-6294a90ad0f4
SPL set ID
18e7fc6b-b40a-f790-e063-6294a90ad0f4
Package NDC
65692-0577-1
Is original packager
true
UNII
4X49Y0596W, G63QQF2NOX, 5A68WGF6WM, V06SV4M95S
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.