CAROLS DAUGHTER MONOI SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and octocrylene spray

Carols Daughter Monoi Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Carols Daughter Monoi Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, L'Oreal USA, Inc., Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 8.8%

Octisalate 4.9%

Octocrylene 5.9%

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 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.

- keep away from face to avoid breathing it

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:

● spray liberally and spread evenly by hand 15 minutes before sun exposure

● hold container 4 to 6 inches from the skin to apply

● do not spray directly into face. Spray on hands then apply to face.

● do not apply in windy conditions

● use in a well-ventilated area

● reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

● 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. – 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

isopropyl myristate, caprylic/capric triglyceride, dicaprylyl ether, C12-15 alkyl benzoate, olea europaea (olive) fruit oil, sorbitan trioleate, ethylhexyl palmitate, dimethicone, fragrance, cocos nucifera (coconut) oil, tocopherol, hydroxypalmitoyl sphinganine, hydroxycitronellal, eugenol, limonene, pentaerythrityl tetra-di-t-butyl hydroxyhydroxcinnamate, benzyl salicylate, benzyl alcohol, benzyl benzoate, linalool, capryloyl salicylc acid, alpha-isomethyl ionone, acrylates/dimethicone copolymer, sorbitan oleate, sorbitan laurate, gardenia taitensis flower, geraniol, myristyl malate phosphonic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAROLS DAUGHTER MONOI SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-398
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	88 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	59 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OLIVE OIL (UNII: 6UYK2W1W1E)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYPALMITOYL SPHINGANINE (UNII: NR33W2353T)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
EUGENOL (UNII: 3T8H1794QW)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
GERANIOL (UNII: L837108USY)
MYRISTYL MALATE PHOSPHONIC ACID (UNII: M1533CYO51)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-398-01	1 in 1 CARTON	03/16/2018
1		148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/16/2018

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-398)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-398)