PRIME TIME DAILY PROTECTING PRIMER SPF 30- spf 30 prime time primer lotion 
Autumn Harp Inc.

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Prime Time Daily Protecting Primer SPF 30

Drug Facts

Active Ingredients

Titanium Dioxide 3.1%

Zinc Oxide 10.49%

Purpose

Sunscreen

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 rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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:

Other Information

Protect this product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Undecane, Polyglyceryl-6 Polyricinoleate, Tapioca Starch, Glycerin, Tridecane, Magnesium Sulfate, Polyglyceryl-2 Isostearate, Tocopherol, Hydrogenated Vegetable Oil, Phenoxyethanol, Glyceryl Isostearate, Disteardimonium Hectorite, Polyhydroxystearic Acid, Propanediol, Bisabolol, Stearic Acid, Iron Oxide (CI 77492), Alumina, 1,2-Hexanediol, Isononyl Isononanoate, Camellia Japonica Seed Oil, Theobroma Cacao (Cocoa) Extract, Butylene Glycol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Biosaccharide gum-4, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Propylene Carbonate.

Questions?

Call toll free 1-888-795-4747

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PRIME TIME DAILY PROTECTING PRIMER SPF 30 
spf 30 prime time primer lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.49 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
UNDECANE (UNII: JV0QT00NUE)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TRIDECANE (UNII: A3LZF0L939)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0364-21 in 1 CARTON01/02/2023
1NDC:51514-0364-130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/02/2023
Labeler - Autumn Harp Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp Inc.064187883manufacture(51514-0364)

Revised: 1/2024
Document Id: f2619092-3e80-5105-e053-2a95a90a3f5a
Set id: f2619092-3e7f-5105-e053-2a95a90a3f5a
Version: 1
Effective Time: 20240103
 
Autumn Harp Inc.