Rocky Mountain Sunscreen

Manufacturer: Creative Cosmetics Inc. dba CCI | Creative Cosmetics Inc dba CCI
Effective date: 2010-06-01
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:53:07

Label at a glance#

ProductRocky Mountain Sunscreen

Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1-888-356-8899

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients Purpose

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

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

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

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

OTC - PURPOSE SECTION

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 SECTION

Warnings:

For external use only.

Keep out of eyes; rinse with water to remove

OTC - STOP USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rocky Mountain Sunscreen

spf 35

Broad Spectrum UVA/UVB

Hypoallergenic Fragrance Free

Greaseless Very Water Resistant

1 Gallon (3.78 LITERS)

Oxybenzone Free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59260-035-09	2021-10-27	C162847	48780-1	956f9ecf-d554-621f-e053-dbdaa90a74ad	Rocky Mountain Sunscreen SPF 35 (1 Gallon) Oxybenzone Free www.rmsunscreen.com Rocky Mountain Sunscreen SPF 35 features a unique Oxybenzone free formula. It contains Titanium Dioxide for superior UVA protection, and immediate protection from the sun.
59260-035-09	2019-10-21	C162847	48780-1	956f9ecf-d554-621f-e053-dbdaa90a74ad	Rocky Mountain Sunscreen SPF 35 (1 Gallon) Oxybenzone Free www.rmsunscreen.com Rocky Mountain Sunscreen SPF 35 features a unique Oxybenzone free formula. It contains Titanium Dioxide for superior UVA protection, and immediate protection from the sun.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	4
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	4
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	4
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	4
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	4
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	4
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	4
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	4
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	4
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	4
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Rocky Mountain Sunscreen
Octinoxate, octisalate, octocrylene, titanium dioxide
OCTINOXATE
OCTISALATE
OCTOCRYLENE
TITANIUM DIOXIDE
CETYL ALCOHOL
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
POLYSORBATE 60
VITAMIN A PALMITATE
STEARIC ACID
.ALPHA.-TOCOPHEROL ACETATE, D-
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59260-035	59260-035-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
CETYL ALCOHOL	936JST6JCN	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
STEARIC ACID	4ELV7Z65AP	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	AEROSOL, FOAM / TOPICAL		30 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / TOPICAL	2.85 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / VAGINAL	0.03 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 13 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	EMULSION / ORAL	20 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii candidate
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cf43bb2e-4d50-2cf3-e053-2995a90a22e9			a101abfa-756e-4dc9-aedf-c508dac9fac0	2021-10-26	Warnings	Exact identifier spl set id: a101abfa-756e-4dc9-aedf-c508dac9fac0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.