CREMO SUNSCREEN- avobenzone, octisalate, octocrylene lotion

Cremo Sunscreen by

Drug Labeling and Warnings

Cremo Sunscreen by is a Otc medication manufactured, distributed, or labeled by Cremo company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

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 Center right away.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• 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 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

STORAGE AND HANDLING

Other information

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients Acrylamide/Sodium Acroylyldimethyl 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

SPL UNCLASSIFIED SECTION

cremocompany.com

Distributed by Cremo Company LLC, Laguna Beach, CA 92651

(800) 853-1762 © 2019 Cremo Co. Not tested on Animals.

PRINCIPAL DISPLAY PANEL

Cremo®

Astonishingly Superior®

FACE LOTION WITH SUNSCREEN

PREVENTATIVE FORMULA

HYDRATES & NOURISHES WHILE PROTECTING SKIN FROM THE ELEMENTS

BROAD SPECTRUM SPF 20

MOISTURIZER + SUN PROTECTION

Essential skincare

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

CREMO SUNSCREEN 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71825-102
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POMEGRANATE (UNII: 56687D1Z4D)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71825-102-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2020

Labeler - Cremo company (078708508)