OLAY REGENERIST MINERAL SUNSCREEN HYDRATING MOISTURIZER BROAD SPECTRUM SPF 30- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
The Procter & Gamble Manufacturing Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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
Authorization status:
OTC monograph not final
Authorization number:
69423-488-50

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OLAY REGENERIST MINERAL SUNSCREEN HYDRATING MOISTURIZER BROAD

SPECTRUM SPF 30- zinc oxide lotion

The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Olay

Regenerist Mineral Sunscreen Hydrating Moisturizer Broad Spectrum SPF 30

Drug Facts

ZINC OXIDE 17.5%

Active ingredients

Purpose

Zinc Oxide 17.5%

Sunscreen

Us es

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.

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use 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 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

children under 6 months: ask a doctor

Other information

protect this product from excessive heat and direct sun

®

Inactive ingredients

Water, caprylic/capric triglyceride, isohexadecane, glycerin, steareth-21, polyhydroxystearic acid,

polyacrylamide, stearyl alcohol, triethoxycaprylylsilane, C13-14 isoparaffin, behenyl alcohol,

hydroxyacetophenone, phenoxyethanol, cetyl alcohol, steareth-2, laureth-7, disodium EDTA,

niacinamide, tocopheryl acetate, palmitoyl pentapeptide-4

Distr. by PROCTER & GAMBLE,

CINCINNATI, OH 45202

Questions or comments?

Call 1-800-285-5170

PRINCIPAL DISPLAY PANEL - 50 mL Carton

OLAY ®

REGENERIST

SPF30

Mineral

Sunscreen

HYDRATING MOISTURIZER

BROAD SPECTRUM SPF 30

50 mL (1.7 FL OZ)

OLAY REGENERIST MINERAL SUNSCREEN HYDRATING MOISTURIZER

BROAD SPECTRUM SPF 30

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 423-48 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

17.5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

The Procter & Gamble Manufacturing Company

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

STEARETH-2 1 (UNII: 53J3F32P58 )

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

DO CO SANO L (UNII: 9 G1OE216 XY)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

STEARETH-2 (UNII: V56 DFE46 J5)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

HYDRO XYACETO PHENO NE (UNII: G1L3HT4CMH)

NIACINAMIDE (UNII: 25X51I8 RD4)

PO LYACRYLAMIDE ( 13 0 0 0 0 0 MW) (UNII: SC5Y4X78 TG)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PALMITO YL PENTAPEPTIDE-4 (UNII: KK18 1SM5JG)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 423-48 8 -

1 in 1 CARTON

11/25/20 20

1

50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

11/25/20 20

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2020

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