HERMES PLEIN AIR NATURAL ENHANCING COMPLEXION BALM SPF 30 SUNSCREEN 30 FICELLE- titanium dioxide cream

Hermes Plein Air Natural Enhancing Complexion Balm SPF 30 Sunscreen 30 FICELLE by

Drug Labeling and Warnings

Hermes Plein Air Natural Enhancing Complexion Balm SPF 30 Sunscreen 30 FICELLE by is a Otc medication manufactured, distributed, or labeled by COMPTOIR NOUVEAU DE LA PARFUMERIE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Titanium Dioxide 12,4%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Children under 6 months age: Ask a doctor.
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Reapply immediately after towel drying.
• 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, hats, and sunglasses. Sun Protection Measures.
  
  

Inactive ingredients

AQUA (WATER), METHYL TRIMETHICONE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, DIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, CYCLOPENTASILOXANE, VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER, PENTYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, POLYGLYCERYL-2 DIISOSTEARATE, SORBITOL, PARFUM (FRAGRANCE), DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, SODIUM CITRATE, SODIUM CHLORIDE, STEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, TOCOPHEROL, GLYCINE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BENZYL SALICYLATE, SODIUM HYALURONATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, LIMONENE, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, MORUS ALBA BARK EXTRACT, GERANIOL,  CITRONELLOL, LINALOOL, HYDROXYCITRONELLAL [+/- (MAY CONTAIN) : MICA, CI 77891 (TITANIUM DIOXIDE), CI 77491/CI 77492/ CI 77499 (IRON OXIDES)].

Other information

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

Package Labeling:82494-003-01

Package Labeling:82494-003-17

Package Labeling:82494-003-40

INGREDIENTS AND APPEARANCE

HERMES PLEIN AIR NATURAL ENHANCING COMPLEXION BALM SPF 30 SUNSCREEN 30 FICELLE 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82494-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	124 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
SORBITOL (UNII: 506T60A25R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALUMINUM OXIDE (UNII: LMI26O6933)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCINE (UNII: TE7660XO1C)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
MORUS ALBA BARK (UNII: 7O71A48NDP)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82494-003-01	1 mL in 1 BAG; Type 0: Not a Combination Product	01/15/2022
2	NDC: 82494-003-17	1 in 1 CARTON	01/15/2022
2		17 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82494-003-40	1 in 1 CARTON	01/15/2022
3		40 mL 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	01/15/2022

Labeler - COMPTOIR NOUVEAU DE LA PARFUMERIE (275137834)