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 Ingredients

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 2.5%

Oxybenzone 6.0%

Purpose

Sunscreen

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 well 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.

Directions

Inactive ingredients:

Aloe Vera Leaf Juice, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Methylparaben, Potassium Sorbate, Propylparaben, Sunflower Oil, Sweet Amond Oil, Tocopherol, Water, Xanthan Gum.

Package Label

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: 65692-0519
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.64 g  in 44 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.2 g  in 44 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.32 g  in 44 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.1 g  in 44 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.3 g  in 44 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
METHYLPARABEN (UNII: A2I8C7HI9T)
GRAPE SEED OIL (UNII: 930MLC8XGG)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL ALCOHOL (UNII: 936JST6JCN)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	TROPICAL FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0519-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/17/2020

Labeler - Raining Rose, Inc (083819404)