CLEAR SUNSCREEN SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene gel

Clear Sunscreen SPF 30 Broad Spectrum by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 3% Sunscreen

Homoslatate 15% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 2.79% Sunscreen

PURPOSE

Uses

• Helps prvent 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.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

Warnings

• For external use only
• Do not use on broken or damaged skin
• When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
• After 40 minutes of swimming or sweating
• at least every 2 hours
• Sun Protections 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 am- 2pm
• wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients Butyloctyl Salicylate, Capric/Caprylic Triglyceride, Dicaprylyl Ether, DImethicone/Bis-Isobutyl PPG-20 Crosspolymer, Fragrance, Isododecane, Methyl Dihydroabietate, Silica.

PRINCIPAL DISPLAY PANEL

Cremo Clear Sunscreen

for face, hairline & Scalp

SPF 30 Broad Spectrum

2 FL OZ (59mL)

INGREDIENTS AND APPEARANCE

CLEAR SUNSCREEN SPF 30 BROAD SPECTRUM 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71825-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.79 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71825-101-01	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/07/2019

Labeler - Cremo company (078708508)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(71825-101)