LAVELIER DIVINE DAY DEFENSE BROAD SPECTRUM SPF 30- octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 7.40% Homosalate 6.20% Octisalate 5.20% Oxybenzone 3.10% Avobenzone 1.50%
Available from:
Florida Private Labeling LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
73191-325-19

LAVELIER DIVINE DAY DEFENSE BROAD SPECTRUM SPF 30- octinoxate, homosalate,

octisilate, oxybenzone and avobenzone cream

Florida Private Labeling LLC

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.

----------

Lavelier

Divine Day Defense Broad Spectrum SPF 30

Active Ingredients

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.20%

Oxybenzone 3.10%

Avobenzone 1.50%

Purpos e

Sunscreen

Us es

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and

consult your physician.

Stop using this product

and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

If accidental ingestion, call the Poison Control Center right away.

Directions

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:

®

Helps prevent sunburn.

After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and

neck and chest daily for optimal results.

Reapply at least every two (2) hours.

Use water resistant sunscreen if swimming or sweating.

For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate,

Tocopherol, Retinyl Palmitate, Hydrolyzed Corallina Officinalis, Aloe Barbadensis Leaf Extract,

Camellia Sinensis Leaf Extract, Sodium PCA, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Carbomer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.

Package/Label Principal Display Panel

lavelier

Divine Day Defense

BROAD SPECTRUM SPF 30

Divine Dèfense Jour

CORAL LUMINOUS | Brightening Collection

60g / 2.11oz

Label

LAVELIER DIVINE DAY DEFENSE BROAD SPECTRUM SPF 30

octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream

limit time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats and sunglasses

®

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7319 1-325

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

7.4 g in 10 0 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

6 .2 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

5.2 g in 10 0 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

3.1 g in 10 0 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

1.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

MYRISTIC ACID (UNII: 0 I3V7S25AW)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7319 1-325-19

1 in 1 CARTON

0 8 /0 1/20 19

1

6 0 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 8 /0 1/20 19

Florida Private Labeling LLC

Labeler -

Florida Private Labeling LLC (081081732)

Revised: 8/2019

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