ROYAL AND ANCIENT SUNCREEN- zinc oxide, octinoxate, octisalate, and oxybenzone lotion 
R & R Lotion, Inc

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.

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Royal & Ancient Suncreen

Drug Facts

Active IngredientsPurpose  
Octinoxate5.9%Sunscreen
Octisalate3.8%Sunscreen
Oxybenzone4.7%Sunscreen
Zinc Oxide6.4%Sunscreen

Uses

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 a rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 of 15 or higher and other sun protection measures including:

 
  • limit time in the sun, especially from 10am-2pm
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Purified DI Water, Octyl Stearate/Octyl Palmitate/Dioctyl Adipate, Propylene Glycol, Glyceryl Stearate & Peg 100, Cetearyl Alcohol & Ceteareth 20, Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Crodafos N3N, and Vitamin E.

Other Information

Comment/Questions?

Call 1-888-860-7424

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Label

ROYAL & ANCIENT

SUNSCREEN
SPF 30+
BROAD SPECTRUM

80 MINUTE WATER RESISTANCE

1.7 FL. OZ. (50ML) e

PRINCIPAL DISPLAY PANEL - 50 ML Bottle Label
ROYAL AND ANCIENT SUNCREEN 
zinc oxide, octinoxate, octisalate, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide64 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate59 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate38 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone47 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Methylparaben (UNII: A2I8C7HI9T)  
Diethylhexyl Adipate (UNII: MBY1SL921L)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
Diethanolamine Oleth-3 Phosphate (UNII: Y67NX5905E)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Propylparaben (UNII: Z8IX2SC1OH)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
Imidurea (UNII: M629807ATL)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-104-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
2NDC:59555-104-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
3NDC:59555-104-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/21/2015
Labeler - R & R Lotion, Inc (062979000)

Revised: 1/2021
Document Id: 14cd89a0-9a49-4fc0-b622-564789e40205
Set id: 0f267ee9-d0e5-4a27-9ea8-a8fe65a5e7e7
Version: 3
Effective Time: 20210114
 
R & R Lotion, Inc