ROCKY MOUNTAIN SUNSCREEN- octinoxate, octisalate, octocrylene, titanium dioxide cream

Rocky Mountain Sunscreen by

Drug Labeling and Warnings

Rocky Mountain Sunscreen by is a Otc medication manufactured, distributed, or labeled by Creative Cosmetics Inc. dba CCI, Creative Cosmetics Inc dba CCI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients                                 Purpose

Octinoxate 7.5%.....................................Sunscreen

Octisalate  5.0%................................... Sunscreen

Octocrylate 10.0%.................................Sunscreen

Titanium Dioxide 1.3%.......................Sunscreen

PURPOSE

Uses:

Higher SPF level gives more sunburn protection

Moisturizes: helps prevent and protects against dry skin

Very Water Resistant: retains SPF after 80 min of activity in water

Provides high protection against sunburn

WARNINGS

Warnings:

For external use only.

Keep out of eyes; rinse with water to remove

STOP USE

Stop use and ask a doctor if rash or irritation develops and lasts.

DOSAGE & ADMINISTRATION

Directions:

Apply evenly and liberally to cool dry skin 15-30 minutes before sun exposure.

Reapply as often as necessary, especially after swimming, heavy sweating or towel drying.

For children under 6 months of age: ask a doctor

INDICATIONS & USAGE

Inactive Ingredients: Aloe Barbadensis Leaf juice, cetyl alcohol, dicaprylyl maleate, DMDM Hydantoin (and) iodopropynyl butylcarbamate, hydrogenated polysobutene, hydroxyethyl acrylate/sodium acryloyldimethyl Taurate Copolymer (and isohexadecane (and polysorbate 60, Retinyl Palmitate (Vitamin A), Stearic Acid, Tocopheryl Acetate (Vitamin E), Trilaureth-4 Phosphate, water

SPL UNCLASSIFIED SECTION

Rocky Mountain Sunscreen

Manufactured for

Rocky Mountain Sunscreen, Denver, CO

Order line--1-888-356-8899

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Rocky Mountain Sunscreen

spf 35

Broad Spectrum UVA/UVB

Hypoallergenic    Fragrance Free

Greaseless   Very Water Resistant

1 Quart (946 ml)


Oxybenzone Free

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROCKY MOUNTAIN SUNSCREEN 
octinoxate, octisalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59260-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
POLYSORBATE 60 (UNII: CAL22UVI4M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59260-135-03	946 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/19/2010

Labeler - Creative Cosmetics Inc. dba CCI (119245561)

Registrant - Creative Cosmetics Inc dba CCI (119245561)

Establishment
Name	Address	ID/FEI	Business Operations
Creative Cosmetics Inc dba CCI		119245561	manufacture