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NDC 00869-0995-26 Octinoxate, Octisalate, Avobenzone 30.6; 76.5; 51 mg/mL; mg/mL; mg/mL Details

Octinoxate, Octisalate, Avobenzone 30.6; 76.5; 51 mg/mL; mg/mL; mg/mL

Octinoxate, Octisalate, Avobenzone is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Vi-Jon. The primary component is AVOBENZONE; OCTINOXATE; OCTISALATE.

Product Information

NDC	00869-0995
Product ID	0869-0995_098f76d7-dfeb-433e-9422-011b93dfee9d
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	Octinoxate, Octisalate, Avobenzone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Octisalate, Avobenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30.6; 76.5; 51
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; OCTINOXATE; OCTISALATE
Labeler Name	Vi-Jon
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00869-0995-26 (00869099526)

Pricing Information	N/A
NDC Package Code	0869-0995-26
Billing NDC	00869099526
Package	141 mL in 1 BOTTLE, PLASTIC (0869-0995-26)
Marketing Start Date	2016-02-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eeb04e82-0a5c-40ca-8cc2-eadd7451eca1 Details

Active ingredients

Octinoxate 7.5%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor if

rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions

apply liberally 15 minutes before sun exposure
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 highter and other sun protection measures including:
limit the 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 from excessive heat and direct sun
may stain some fabrics

Inactive ingredients

water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PEG-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate

claims

This product is not manufactured or distributed by Galdema Laboatories, L.P., distributor of Cetaphil Daily Facial Moisturizer SPF 15

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

principal display panel

mountain

falls

Compare

to Olay

won't

clog Pores

UVA/UVB

protection

vitamin

E & C

enriched

SPF

moisturizing

beuty lotion

broad spectrum

SPF 15

sunscreen

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

OCTINOXATE, OCTISALATE, AVOBENZONE

octinoxate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0869-0995
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	76.5 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.0 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYL METHACRYLATE (UNII: 196OC77688)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TOCOPHEROL (UNII: R0ZB2556P8)
CARBOMER 940 (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEARETH-2 (UNII: V56DFE46J5)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0869-0995-26	141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/25/2016

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(0869-0995)

Revised: 11/2022

Document Id: 098f76d7-dfeb-433e-9422-011b93dfee9d

Set id: eeb04e82-0a5c-40ca-8cc2-eadd7451eca1

Version: 8

Effective Time: 20221122