ROSE SIL VOUS PLAIT SPF30 GENTLE MINERAL SUNSCREEN- zinc oxide, titanium dioxide lotion

ROSE SIL VOUS PLAIT SPF30 GENTLE MINERAL SUNSCREEN by

Drug Labeling and Warnings

ROSE SIL VOUS PLAIT SPF30 GENTLE MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Everyday Group Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 11.25%

Titanium Dioxide 1.50%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early signs of 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.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying 
• 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 a.m. to 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

Water (Aqua), Organic Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Coconut Alkanes, Coco-Caprylate, Cetearyl Glucoside, Cetyl Palmitate, Galactoarabinan, Rosa Centifolia Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Sorbitan Oleate, Sorbitan Palmitate, Anhydroxylitol, Coco-Caprylate/Caprate, Xylitylglucoside, Xylitol, Glyceryl Isostearate, Polyhydroxystearic Acid, Tocopherol, Sorbitan Isostearate, Caprylyl/Capryl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Jojoba Esters, Phenoxyethanol, Benzyl Alcohol.

Other information

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

Package Labeling:

INGREDIENTS AND APPEARANCE

ROSE SIL VOUS PLAIT SPF30 GENTLE MINERAL SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72098-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	112.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE (UNII: 4828G836N6)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GALACTOARABINAN (UNII: SL4SX1O487)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72098-003-04	43 mL in 1 TUBE; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/18/2020

Labeler - Everyday Group Limited (664624682)