HILTON SPF 30 MINERAL SUNSCREEN- zinc oxide cream ORIOR SPF 30 MINERAL SUNSCREEN- zinc oxide cream

Orior SPF 30 Mineral Sunscreen by

Drug Labeling and Warnings

Orior SPF 30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Body One, LLC, Solo Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 21.6%

Purpose

Sunscreen

Uses

• * Helps prevent sunburn.
• * higher SPF five more sunburn protection
• * retains SPF after 40 minutes of activity in the water
• * If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer of early skin aging.

For External Use Only

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to removed. Stop use and ask a doctor if rash of irritation develops and lasts.

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

Directions

• * Apply liberally and evenly 15 minutes before sun exposure.
• * Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Aqua/water, ButylOctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Disteardimmonium Hectorite, EthylHexylglycerin, EthylhexylMethoxycrylene, Fragrance, Glycerine, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid.

Questions or comments?

1-833-263-9663

PRINCIPAL DISPLAY PANEL - 59 ml. Bottle Label

Hilton
WAIKOLOA VILLAGE®

MINERAL
SUNSCREEN

SPF 30
BROAD SPECTRUM

2 fl. oz. (59 ml.)
www.hiltonwaikoloavillage.com

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

ORIOR

MINERAL
SUNSCREEN
LOTION

SPF 30
BROAD SPECTRUM

5.0 fl.oz. 150 mL

INGREDIENTS AND APPEARANCE

HILTON SPF 30 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73563-335
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GUAIETOLIN, (S)- (UNII: L7635M8189)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C13-15 Alkane (UNII: 114P5I43UJ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
LINALYL ACETATE (UNII: 5K47SSQ51G)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
TETRAHYDROLINALOOL (UNII: UM4XS5M134)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73563-335-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2023
2	NDC: 73563-335-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2023

ORIOR SPF 30 MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73563-638
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GUAIETOLIN, (S)- (UNII: L7635M8189)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C13-15 Alkane (UNII: 114P5I43UJ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
LINALYL ACETATE (UNII: 5K47SSQ51G)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
TETRAHYDROLINALOOL (UNII: UM4XS5M134)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73563-638-05	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2023
2	NDC: 73563-638-02	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2023

Labeler - Body One, LLC (117376115)

Registrant - Solo Laboratories Inc (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
Solo Laboratories Inc		078831987	MANUFACTURE(73563-335, 73563-638) , LABEL(73563-335, 73563-638) , PACK(73563-335, 73563-638)