Search by Drug Name or NDC

NDC 68726-0264-12 Active 5; 8.5; 8 g/100g; g/100g; g/100g Details

Active 5; 8.5; 8 g/100g; g/100g; g/100g

Active is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CP Skin Health Group, Inc.. The primary component is OCTISALATE; OCTOCRYLENE; ZINC OXIDE.

Product Information

NDC	68726-0264
Product ID	68726-264_e2988284-5d77-6637-e053-2a95a90acf1e
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	Active
Proprietary Name Suffix	SPF 45
Non-Proprietary Name	Broad Spectrum
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	5; 8.5; 8
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Labeler Name	CP Skin Health Group, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68726-0264-12 (68726026412)

Pricing Information	N/A
NDC Package Code	68726-264-12
Billing NDC	68726026412
Package	85 g in 1 TUBE (68726-264-12)
Marketing Start Date	2020-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b6c3adfb-d20a-1b67-e053-2a95a90a4b4e Details

Active ingredients

Octisalate 4.9%, Octocrylene 8.1%, Zinc Oxide 8%

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Direction), 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

Stop use and ask a doctor if skin rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

Children under 6 months: ask a doctor

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 borad specturm SPF value of 15 or higher and other skin protecting measures including:

- limit time in the sun, specially from 10a.m. - 2 p.m.

- weare long-sleeved shirts, pants, hats, and sunglasses

Other information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer

Bisabolol

Butyloctyl Salicylate

C13-14 Alkane

Caffeine

Caprylyl Methicone

Cetearyl Alcohol

Cetearyl Olivate

Cetyl Palmitate

Ethyl Ferulate

Ethylhexyl Methoxycrylene

Ethylhexylglycerin

Isohexadecane

Neopentyl Glycol Diheptanoate

Phenoxyethanol

Polyester-7

Polysorbate 80

Propanediol

Sodium Gluconate

Sorbitan Oleate

Sorbitan Olivate

Sorbitan Palmitate

Styrene/Acrylates Copolymer

Triethoxycaprylylsilane

Water

Xanthan Gum

Questions or comments?

877.722.7546

package label

INGREDIENTS AND APPEARANCE

ACTIVE SPF 45

broad spectrum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68726-264
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PROPANEDIOL (UNII: 5965N8W85T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYESTER-7 (UNII: 0841698D2F)
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
XANTHAN GUM (UNII: TTV12P4NEE)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ETHYL FERULATE (UNII: 5B8915UELW)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68726-264-12	85 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
2	NDC:68726-264-37	7.4 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2020	05/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2020

Labeler - CP Skin Health Group, Inc. (611921669)

Revised: 6/2022

Document Id: e2988284-5d77-6637-e053-2a95a90acf1e

Set id: b6c3adfb-d20a-1b67-e053-2a95a90a4b4e

Version: 2

Effective Time: 20220629