Presage Moisturizer SPF 15

Presage Moisturizer SPF 15 by

Drug Labeling and Warnings

Presage Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by ASA Universal Inc. dba: Sonage. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRESAGE MOISTURIZER SPF 15- zinc oxide and titanium dioxide cream 
ASA Universal Inc. dba: Sonage

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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Presage Moisturizer SPF 15

Active ingredients

Zinc Oxide 5.0%

Titanium Dioxide 2.5%

Purpose

Sunscreen

Uses

• Protects against UVA/UVB & infrared rays
• Continued use reduces the risk of skin cancer
• Helps prevent sunburn & photodamage

Warnings

For external use only.

When Using

Keep product out of eyes. Rinse with water to remove.

Stop Use

And ask a doctor if continuous rash/irritation develops.

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 6 months of age and older: apply evenly to all exposed areas before sun exposure & reapply often for Broad Spectrum UVA/UVB protection. Children under 2 years of age: should use sunscreen products with a minimum SPF of 15. Children under 6 months of age: ask a doctor.

Inactive Ingredients

Aqua, Prunus Amygdalus Dulcis (Almond) Oil, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Glycerin, Cetearyl Alcohol, Ceteareth-20, Glyceryl Stearate, Corylus Americana (Hazel) Seed Oil, Superoxide Dismutase, Aloe Barbadensis (Aloe Vera) Leaf Extract, Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Glycoproteins, Hydrolyzed RNA, Lactoferrin, Silk Amino Acids, Coconut Alkanes, Polyhydroxystearic, Stearic Acid, Alumina, Coco-Caprylate/Caprate, Dimethicone, Disodium EDTA, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Ethylhexylglycerin, Beta Carotene, Cyclopentasiloxane, Polysorbate 60, Cetearyl Olivate, Sorbitan Olivate, Xanthan Gum, Sodium Hydroxide, Parfum

Package/Label Principal Display Panel

SONÄGE®
fondée 1994

PRESAGE MOISTURIZER SPF 15
Broad Spectrum UVA/UVB

net 50 ml. e 1.7 fl. oz.

Carton Label

Carton Label

PRESAGE MOISTURIZER SPF 15 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69546-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALMOND OIL (UNII: 66YXD4DKO9)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CORYLUS AMERICANA NUT OIL (UNII: KTR1NR9675)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
COCONUT ALKANES (UNII: 1E5KJY107T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69546-311-01	50 g in 1 JAR; Type 0: Not a Combination Product	03/01/2015	09/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2015	09/30/2018

Labeler - ASA Universal Inc. dba: Sonage (054687895)

Revised: 12/2019

Document Id: 2183800f-65ad-499d-b475-396be9f8ca55

34390-5

Set id: bb29a224-39c6-4278-8b15-bf94a01b7049

Version: 3

Effective Time: 20191230

 

ASA Universal Inc. dba: Sonage