BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN lotion

Broad Spectrum SPF 30 Tropical Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF 30 Tropical Sunscreen by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

PURPOSE

Sunscreen

INDICATIONS & 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 & 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN 
broad spectrum spf 30 tropical sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0577
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.5 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 g  in 30 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALMOND OIL (UNII: 66YXD4DKO9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPANEDIOL (UNII: 5965N8W85T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0577-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/20/2024

Labeler - Raining Rose, Inc (083819404)

Registrant - Raining Rose, Inc (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc		083819404	manufacture(65692-0577)