SENSITIF RENEWAL CREAM DAILY PROTECTION SPF 30 BROAD SPECTRUM UVA UVB SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB Sunscreen by

Drug Labeling and Warnings

Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB Sunscreen 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

Avobenzone 3.0%  Homosalate 10.0%  Octisalate 5.0%  Octocrylene 1.0%  Oxybenzone 5.0%

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: Sun Protection Measures.
• 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

Other information

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

Inactive ingredients

Water, Butylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Potassium Cetyl Phosphate, Stearic Acid, Oligopeptide-24, Polysorbate 60, Polyester-8, Sclerotium Gum, Bisabolol, Phenoxyethanol, Dimethicone, Sodium PCA, Squalane, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Allantoin, Caprylyl Glycol, Phytosterols, Chlorphenesin, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Glycolipids, Sodium Hyaluronate, Citrus Aurantium Dulcis (Orange) Oil, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Citral, Linalool, Limonene.

Questions or comments?

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

Package Labeling: 82691-035-01

Package Labeling:82691-035-00

INGREDIENTS AND APPEARANCE

SENSITIF RENEWAL CREAM DAILY PROTECTION SPF 30 BROAD SPECTRUM UVA UVB SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82691-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
LEVOMENOL (UNII: 24WE03BX2T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
OLIVE OIL (UNII: 6UYK2W1W1E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
GINGER (UNII: C5529G5JPQ)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82691-035-00	1 in 1 CARTON	12/01/2017
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 82691-035-01	5 mL in 1 JAR; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2017

Labeler - RV Skincare LLC (080986653)