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NDC 11822-3430-01 Daylogic Tinted Daily Moisturizer SPF 30 20; 75; 60; 50 mg/mL; mg/mL; mg/mL; 1/mL Details

Daylogic Tinted Daily Moisturizer SPF 30 20; 75; 60; 50 mg/mL; mg/mL; mg/mL; 1/mL

Daylogic Tinted Daily Moisturizer SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. The primary component is ENSULIZOLE; OCTINOXATE; OXYBENZONE; ZINC OXIDE.

Product Information

NDC	11822-3430
Product ID	11822-3430_5a2d31d9-6369-4b11-b4a6-bb5fcfc1139b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Daylogic Tinted Daily Moisturizer SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ensulizole, Octinoxate, Oxybenzone, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	20; 75; 60; 50
Active Ingredient Units	mg/mL; mg/mL; mg/mL; 1/mL
Substance Name	ENSULIZOLE; OCTINOXATE; OXYBENZONE; ZINC OXIDE
Labeler Name	Rite Aid Corporation
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 11822-3430-01 (11822343001)

Pricing Information	N/A
NDC Package Code	11822-3430-1
Billing NDC	11822343001
Package	50 mL in 1 TUBE (11822-3430-1)
Marketing Start Date	2017-08-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 238c2336-dbff-4fbb-bcd7-2b3bc9339a11 Details

Active ingredients

Ensulizole 2%

Octinoxate 7.5%

Oxybenzone 6%

Zinc Oxide 5%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protectio 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.

Sto 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

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 sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: ask a doctor

Other information

protect this product from excessive heat and direct sun.

Inactive ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Caprylyl Methicone, Glcerin, Cetearyl Alcohol, Isohexadecane, Trimethylolpropane Triethylhexanoate, PEG-100 Stearate, Glyceryl Stearate, Butyloctyl Salicylate, Triethanolamine, Calcium Pantothenate, Bisabolol, Dicetyl Phosphate, Ceteth-10 Phosphate, Propylene Glycol, Butylene Glycol, Codium Tomentosum Extract, Caprylic/Capric Triglyceride, Sodium Acrylates Copolymer, Xanthan Gum, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Isobtuylparaben, Butylparaben, Iron Oxides (CI 77491, CI 77492, CI 77499).

Questions or comments?

1-866-695-3030

Label copy

INGREDIENTS AND APPEARANCE

DAYLOGIC TINTED DAILY MOISTURIZER SPF 30

ensulizole, octinoxate, oxybenzone, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-3430
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOHEXADECANE (UNII: 918X1OUF1E)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TROLAMINE (UNII: 9O3K93S3TK)
DOCOSANOL (UNII: 9G1OE216XY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
LEVOMENOL (UNII: 24WE03BX2T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CODIUM TOMENTOSUM (UNII: B8B45BRU87)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-3430-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/13/2017

Labeler - Rite Aid Corporation (014578892)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(11822-3430)

Revised: 8/2017

Document Id: 5a2d31d9-6369-4b11-b4a6-bb5fcfc1139b

Set id: 238c2336-dbff-4fbb-bcd7-2b3bc9339a11

Version: 1

Effective Time: 20170814