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NDC 11822-0714-03 Sunscreen 30.3; 101; 50.5; 101 mg/mL; mg/mL; mg/mL; mg/mL Details

Sunscreen 30.3; 101; 50.5; 101 mg/mL; mg/mL; mg/mL; mg/mL

Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	11822-0714
Product ID	11822-0714_b164a3fe-4df6-4bc3-90b7-f03aab024e1c
Associated GPIs	43994003900340
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	Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30.3; 101; 50.5; 101
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Rite Aid
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 11822-0714-03 (11822071403)

Pricing Information	N/A
NDC Package Code	11822-0714-3
Billing NDC	11822071403
Package	236 mL in 1 BOTTLE, PLASTIC (11822-0714-3)
Marketing Start Date	2021-12-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a9f9ca00-47ba-4aa5-9bf9-7a01daba88b4 Details

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protections 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 swallowed, get medical help or contact a Poison Control Center right away

Directions

■ apply liberally 15 minutes before sun exposure

■ apply to all skin exposed to the sun

■ reapply:

after 80 minutes of swimming or sweating
mmediately 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 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

Inactive ingredients

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, oleth-3, disodium EDTA

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 30.

May stain or damage some fabrics or surfaces.

DISTRIBUTED BY: RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011 www.riteaid.com

principal display panel

Comapre to Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 30*

SPORT

WATER RESISTANT

SUNSCREEN LOTION

UVA/UVB Sunscreen

Won't run when you

start to sweat

Non-greasy

Helps prevent sunburn

BROAD SpECTRUM SPF

NET WT

8 FL. OZ. (236 mL)

INGREDIENTS AND APPEARANCE

SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0714
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.3 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	101 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.5 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	101 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SORBITOL (UNII: 506T60A25R)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
OLETH-3 (UNII: BQZ26235UC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-0714-3	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/02/2021

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11822-0714)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11822-0714)

Revised: 10/2022

Document Id: b164a3fe-4df6-4bc3-90b7-f03aab024e1c

Set id: a9f9ca00-47ba-4aa5-9bf9-7a01daba88b4

Version: 4

Effective Time: 20221005