SENSITIF EYE US SPF 30 BROAD SPECTRUM UVA UVB SUNSCREEN PA- titanium dioxide, zinc oxide cream

Sensitif Eye US SPF 30 Broad Spectrum UVA UVB Sunscreen PA by

Drug Labeling and Warnings

Sensitif Eye US SPF 30 Broad Spectrum UVA UVB Sunscreen PA by is a Otc medication manufactured, distributed, or labeled by RV Skincare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 3.4%

Zinc Oxide 4.9%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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

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 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 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor






Sun Protection Measures.

Other information

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

Inactive ingredients

Aqua (Water, Eau), Dimethicone, Propanediol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Butyloctyl Salicylate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Sodium Chloride, Butylene Glycol, Niacinamide, Caffeine, Oligopeptide-24, Sodium Hyaluronate, Beta-Glucan, Ascorbyl Palmitate, Selaginella Lepidophylla Extract, Punica Granatum Seed Oil, Persea Gratissima (Avocado) Oil, Vitis Vinifera (Grape) Seed Oil, Dipotassium Glycyrrhizate, Polymnia Sonchifolia Root Juice, Calendula Officinalis Flower Extract, Theobroma  Cacao (Cocoa) Seed Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Zingiber Officinale (Ginger) Root Extract, Alteromonas Ferment Extract, Olive Oil Polyglyceryl-6 Esters, Butyrospermum Parkii (Shea) Butter, Bisabolol, Alpha-Glucan Oligosaccharide, Polyglyceryl-3 Polyricinoleate, Lecithin, Isostearic Acid, Sodium Oleate, Glycine Soja (Soybean) Oil, Polyglyceryl-4 Isostearate, Hexyl Laurate, Disteardimonium Hectorite, Polysilicone-11, Caprylyl Glycol, 1,2-Hexanediol, Magnesium Sulfate, Hydroxyacetophenone, Polyglyceryl-6 Pentaoleate, Pentylene Glycol, Stearic Acid, Glycerin, Silica, Polyhydroxystearic Acid, Hydroxyphenyl Propamidobenzoic Acid, Cellulose Acetate, Acrylates/Ammonium Methacrylate Copolymer, Lactobacillus Ferment, Propylene Glycol Stearate, Triethoxycaprylylsilane, Lactobacillus, Magnesium Stearate, Hydrogenated Lecithin, Maltodextrin, Phenoxyethanol, Sodium Benzoate, Benzoic Acid, Disodium EDTA, Alumina, CI 77491/77492/77499 (Iron Oxides), CI 77891 (Titanium Dioxide).

Questions or comments?

Call  M – F 8am – 5pm CST. 1-866-986-7083,

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

SENSITIF EYE US SPF 30 BROAD SPECTRUM UVA UVB SUNSCREEN PA 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82691-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	34 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPANEDIOL (UNII: 5965N8W85T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
CAFFEINE (UNII: 3G6A5W338E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
AVOCADO OIL (UNII: 6VNO72PFC1)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COCOA (UNII: D9108TZ9KG)
GINGER (UNII: C5529G5JPQ)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
SHEA BUTTER (UNII: K49155WL9Y)
LEVOMENOL (UNII: 24WE03BX2T)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM OLEATE (UNII: 399SL044HN)
SOYBEAN OIL (UNII: 241ATL177A)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82691-144-00	1 in 1 CARTON	01/09/2021
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 82691-144-01	1 in 1 CARTON	01/09/2021
2		3 mL in 1 BOTTLE, PUMP; 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	01/09/2021

Labeler - RV Skincare LLC (080986653)