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NDC 62296-8292-02 ULTA FACE SPF 30 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g Details

ULTA FACE SPF 30 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g

ULTA FACE SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ulta. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	62296-8292
Product ID	62296-8292_d45165d4-d9aa-427b-b338-0512db3b2a4e
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	ULTA FACE SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	2; 13; 5; 2; 4
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	Ulta
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62296-8292-02 (62296829202)

Pricing Information	N/A
NDC Package Code	62296-8292-2
Billing NDC	62296829202
Package	88 g in 1 BOTTLE (62296-8292-2)
Marketing Start Date	2016-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 78ed84b3-5dda-4792-83cd-86f63846fef7 Details

Active ingredients

Avobenzone 2.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 4.0%

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.

stop use and ask a doctor

if rash occurs.

keep out of reach of children

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

May stain some fabrics

Directions

apply liberally 15 minutes before sun exposure
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 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor

Inactive Ingredients

Water, Sorbitol, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Palmitic Acid, Sorbitan Isostearate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben.

Other information

protect this product from excessive heat and direct sun

Principal Display Panel

62296-8292-2

SUNCARE

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

OIL-FREE

SUNSCREEN LOTION

FOR FACE

ULTA

3 fl oz/88 ml

INGREDIENTS AND APPEARANCE

ULTA FACE SPF 30

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62296-8292
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PALMITIC ACID (UNII: 2V16EO95H1)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62296-8292-2	88 g in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/17/2015

Labeler - Ulta (608168597)

Name	Address	ID/FEI	Business Operations
Establishment
Playtex Manufacturing Inc.		963501502	manufacture(62296-8292)

Revised: 5/2016

Document Id: d45165d4-d9aa-427b-b338-0512db3b2a4e

Set id: 78ed84b3-5dda-4792-83cd-86f63846fef7

Version: 1

Effective Time: 20160519