Rocky Mountain KIDS Broad Spectrum SPF 30

Dosage form: lotion
Ingredients: AVOBENZONE 3mL in 100mL, HOMOSALATE 10mL in 100mL, OCTINOXATE 7.5mL in 100mL, OCTISALATE 5mL in 100mL, OXYBENZONE 4mL in 100mL
Labeler: Rocky Mountain Sunscreen
NDC Code: 49757-002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Rocky Mountain KIDS Broad Spectrum SPF 30

Drug Facts


Active ingredients

Avobenzoe 3.0%,  Homosalate 10.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%

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 Center right away.

Directions
  • Apply liberally to cool, dry skin 15 minutes before sun exposure.
  • Reapply: after 80 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours
  • Sun Protection 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 10am - 2pm; wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months:  Ask a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cetyl Alcohol, DEA-Cetyl Phosphate, Disodium EDTA, Hydrogenated Polyisobutene, Stearic Acid, Triethanolamine, Water.

Other information

Protect this product container from excessive heat and direct sun.

KIDS Enhanced Bonding Base Formula

ROCKY MOUNTAIN Sunscreen   Dist. by:  Rocky Mountain Sunscreen Arvada, CO 80004   www.rmsunscreen.com  Order Toll-free--1-888-356-8899

ROCKY MOUNTAIN Sunscreen Enhanced Bonding Base  KIDS BROAD SPECTRUM SPF 30 Water Resistant (80 MINUTES)   Fragrance Free   Moisturizing    Greaseless   1 GALLON (3.78 LITERS)

Rocky Mountain KIDS Broad Spectrum SPF 30

ROCKY MOUNTAIN KIDS BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49757-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE10 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) 
ALOE VERA LEAF 
BENZYL ALCOHOL 
CETYL ALCOHOL 
DIETHANOLAMINE CETYL PHOSPHATE 
EDETATE DISODIUM 
HYDROGENATED POLYBUTENE (1300 MW) 
STEARIC ACID 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49757-002-00946 mL in 1 BOTTLE
2NDC:49757-002-013785.41 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/27/2012
Labeler - Rocky Mountain Sunscreen (032180460)
Registrant - Creative Cosmetics Inc (119245561)
Establishment
NameAddressID/FEIOperations
Creative Cosmetics Inc119245561manufacture

Revised: 04/2012
 
Rocky Mountain Sunscreen

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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