PRIME TIME DAILY PROTECTING PRIMER SPF 30- spf 30 prime time primer lotion

Prime Time Daily Protecting Primer SPF 30 by

Drug Labeling and Warnings

Prime Time Daily Protecting Primer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 3.1%

Zinc Oxide 10.49%

Purpose

INDICATIONS & USAGE

Sunscreen

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and 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 rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

Directions

• For sunscreen use:
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least 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 value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 am - 2 pm
• wear long sleeve shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

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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Image Content

INGREDIENTS AND APPEARANCE

PRIME TIME DAILY PROTECTING PRIMER SPF 30 
spf 30 prime time primer lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0364
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.49 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0364-2	1 in 1 CARTON	01/02/2023
1	NDC: 51514-0364-1	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/02/2023

Labeler - Autumn Harp Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp Inc.		064187883	manufacture(51514-0364)