CREMO FACE WITH SUNSCREEN SPF20- avobenzone, octisalate, octocrylene lotion

CREMO Face with Sunscreen SPF20 by

Drug Labeling and Warnings

CREMO Face with Sunscreen SPF20 by is a Otc medication manufactured, distributed, or labeled by Cremo Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7.5%

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

Do not use 

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure.
• reapply.
• at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Sun protection measures:
• spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value 15 of higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 pm.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Aloe Vera Juice, Water (Aqua), Green Tea Extract, Carbomer, Cetyl Alcohol, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexylglycerin, Sunflower Oil, Isohexadecane, Phenoxyethanol, Polysorbate 20, Polysorbate-80, Propylene Glycol, Pomegranate Extract, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

CREMO FACE WITH SUNSCREEN SPF20 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71825-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POMEGRANATE (UNII: 56687D1Z4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71825-205-59	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/20/2019

Labeler - Cremo Company, LLC (078708508)