DAILY DRIVER SUNSCREEN BROAD SPECTRUM SPF 30- homosalate, octisalate, avobenzone, octocrylene cream
Eai-jr 286, 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.

----------

Daily Driver Sunscreen Broad Spectrum SPF 30

Active Ingredients Purpose

Homosalate 5% Sunscreen

Octisalate 5% Sunscreen

Avobenzone 3% Sunscreen

Octocrylene 2.7% 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

Keep out of reach of children

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

Stop use and ask a doctor if rash occurs

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

Directions

• Apply liberally and generously 15 minutes before sun exposure and at least
every 2 hours.

• 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 your 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.

Inactive ingredients:

Water, Isododecane, Dimethicone, Glycerin, Tapioca starch, Pentylene Glycol, Cetearyl Alcohol, Polyurethane-34, Polysilicone-11, Isododecane, Coco-Caprylate/-Caprate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydrolyzed Hibiscus Esculentes Extract, Butylene Glycol, SOdium Polyacrylate, Dextrin, Citrus Sinensis (Blood Orange) Fruit Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Ethylhexyl Stearate, Xanthan Gum, Ammonium Acryloyldeimethyltaurate/VP Copolymer, Fragrance, Chlorphenesin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Tocopheryl Acetate, Trideceth-6, Leuconostoc/Radish root ferment Filtrate, Disodium EDTA, Decyl Glucoside, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Aminomethyl Propanol

Daily Driver

Sun Resistance & anti-aging

Face and Body Lotion

Broad Spectrum SPF 30

Color: Untinted

primary

box

DAILY DRIVER SUNSCREEN BROAD SPECTRUM SPF 30
homosalate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71014-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
WATER (UNII: 059QF0KO0R)
CITRUS SINENSIS WHOLE (UNII: 37673443KL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
ISODODECANE (UNII: A8289P68Y2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
STARCH, TAPIOCA (UNII: 24SC3U704I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
ICODEXTRIN (UNII: 2NX48Z0A9G)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71014-013-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/27/2018	02/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/02/2018	02/01/2022

Labeler - Eai-jr 286, Inc (827896718)

Name	Address	ID/FEI	Business Operations
Establishment
Northwest Cosmetic Laboratories LLC		929572014	manufacture(71014-013)

Revised: 11/2022

Document Id: ed35e9dd-844b-72e1-e053-2a95a90aa882

Set id: 799e358f-f796-4c1c-e053-2991aa0a9fe4

Version: 2

Effective Time: 20221111

Eai-jr 286, Inc