ROYAL AND ANCIENT SUNCREEN- zinc oxide, octinoxate, octisalate, and oxybenzone lotion

Royal and Ancient Suncreen by

Drug Labeling and Warnings

Royal and Ancient Suncreen by is a Otc medication manufactured, distributed, or labeled by R & R Lotion, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients		Purpose
Octinoxate	5.9%	Sunscreen
Octisalate	3.8%	Sunscreen
Oxybenzone	4.7%	Sunscreen
Zinc Oxide	6.4%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer & 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 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

• apply liberally 15 minutes before sun exposure reapply:
  • after 80 minutes of swimming or sweating
  • immediatly after towel drying
  • 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 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

• children under 6 months: Ask a doctor

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

• protect this product from excessive heat and direct sun

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

INGREDIENTS AND APPEARANCE

ROYAL AND ANCIENT SUNCREEN 
zinc oxide, octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	64 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	59 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	38 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	47 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-104-03	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/21/2015
2	NDC: 59555-104-10	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/21/2015
3	NDC: 59555-104-11	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/21/2015

Labeler - R & R Lotion, Inc (062979000)