CAROLS DAUGHTER MONOI SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and octocrylene spray 
L’Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

image of a label

CAROLS DAUGHTER MONOI SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-398
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE59 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-398-011 in 1 CARTON03/16/201801/03/2022
1148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/16/201801/03/2022
Labeler - L’Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-398)
Establishment
NameAddressID/FEIBusiness Operations
Dimensional Merchandising Inc.076693183manufacture(49967-398)

Revised: 1/2023
 
L’Oreal USA Products Inc